Evaluating an advanced double intravenous vasopressor automated system to treat hypotension during spinal anesthesia for cesarean delivery: a randomized controlled trial.

BACKGROUND: The optimal treatment of hypotension during spinal anaesthesia is uncertain. A novel double intravenous vasopressor automated (DIVA) system reduces hypotension compared to standard care, and was subsequently modified to an advanced-DIVA (ADIVA) system. The primary objective was to compare ADIVA versus DIVA on incidence of hypotension (systolic BP (SBP) < 80% baseline). METHODS: We conducted a randomized-controlled trial in women undergoing elective cesarean delivery under spinal anesthesia. SBP and heart rate were measured continuously using a Nexfin monitor. ADIVA delivered 25 µg phenylephrine (heart rate > 60 beats.min-1) or 2 mg ephedrine (heart rate < 60 beats.min-1) at SBP 90 to 110% of baseline, 50 µg phenylephrine or 4 mg ephedrine at SBP 80 to 90%, and 75 µg phenylephrine or 6 mg ephedrine at SBP < 80%. ADIVA calculated the trend of SBP; vasopressors were administered rapidly if SBP trended downward, or 30 s if SBP trended upward. In contrast, DIVA delivered 25 µg phenylephrine or 2 mg ephedrine at SBP 90 to 100% of baseline, and 50 µg phenylephrine or 4 mg ephedrine at SBP < 90%. Boluses were followed by a 10-s lockout. Other outcomes included hypertension (SBP > 120% baseline), vasopressor consumption, clinical outcomes, and performance measures from spinal anesthesia to fetal delivery. RESULTS: We analyzed 94 parturients (ADIVA: n = 46, DIVA: n = 48), with no difference in the incidence of hypotension between ADIVA (78.3%) and DIVA (83.3%, p = 0.677). ADIVA had significantly higher proportion of hypotensive SBP readings, lower phenylephrine consumption and higher umbilical arterial pH. There was no difference in hypertension, bradycardia, ephedrine consumption, intravenous fluid volume, nausea/vomiting, Apgar scores, and umbilical venous pH or lactate. ADIVA maintained SBP higher above baseline with greater fluctuation than DIVA. CONCLUSION: ADIVA was associated with a greater proportion of hypotensive SBP readings, reduced phenylephrine consumption, and increased umbilical arterial pH than DIVA. Further research is needed to determine the optimal method of vasopressor delivery in parturients undergoing cesarean delivery. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov registry (NCT03620942) on 08/08/2018.

An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study.

BACKGROUND: During spinal anaesthesia for caesarean section, haemodynamic instability may lead to maternal and foetal complications. We developed a novel advanced double intravenous vasopressor automated system (ADIVA) by using a continuous blood pressure and heart rate monitor. Treatment of hypotension was based on three criteria: the drug (phenylephrine or ephedrine) according to the heart rate; the dose of vasopressor determined by the degree of hypotension; a fast or slow bolus of vasopressor administered depending on whether there was a negative or positive gradient of SBP changes, respectively. OBJECTIVE: The aim of this pilot study was to investigate the feasibility of the ADIVA algorithm. DESIGN: A prospective pilot study. SETTING: Single obstetrics and gynaecology centre in Singapore. PATIENTS: Women undergoing elective caesarean delivery under spinal anaesthesia. INTERVENTION: Automated administration of ephedrine or phenylephrine based on changes in blood pressure and heart rate (via the ADIVA algorithm) detected on continuous noninvasive haemodynamic monitoring using noninvasive continuous haemodynamic monitor (Nexfin). MAIN OUTCOME MEASURES: The primary outcome was the incidence of hypotension, defined as SBP less than 80% of baseline. The secondary outcome measures were reactive hypertension, total vasopressor requirement, maternal and neonatal outcomes and system performance. RESULTS: Forty-five women were recruited. Thirty-one women (69.9%) had at least one reading of hypotension. SBP was within ±20% of the baseline in a mean ±â€ŠSD of 79.7 ±â€Š17.6% of measurements. Forty-four (97.8%) women required phenylephrine before delivery, while 15 (33.3%) required ephedrine. No rescue medications were required. Three women (6.7%) had nausea and two (4.4%) vomiting. All neonates had APGAR scores of 9 at 5 min. CONCLUSION: The ADIVA system, with noninvasive continuous haemodynamic monitoring, was able to maintain maternal SBP within ±20% of baseline for the vast majority of the measurements. This system had good maternal and foetal outcomes with minimal intervention from the attending anaesthetist. TRIAL REGISTRATION: NCT03620942.

Machine learning approach to needle insertion site identification for spinal anesthesia in obese patients.

BACKGROUND: Ultrasonography for neuraxial anesthesia is increasingly being used to identify spinal structures and the identification of correct point of needle insertion to improve procedural success, in particular in obesity. We developed an ultrasound-guided automated spinal landmark identification program to assist anesthetists on spinal needle insertion point with a graphical user interface for spinal anesthesia. METHODS: Forty-eight obese patients requiring spinal anesthesia for Cesarean section were recruited in this prospective cohort study. We utilized a developed machine learning algorithm to determine the needle insertion point using automated spinal landmark ultrasound imaging of the lumbar spine identifying the L3/4 interspinous space (longitudinal view) and the posterior complex of dura mater (transverse view). The demographic and clinical characteristics were also recorded. RESULTS: The first attempt success rate for spinal anesthesia was 79.1% (38/48) (95%CI 65.0 - 89.5%), followed by successful second attempt of 12.5% (6/48), third attempt of 4.2% (2/48) and 4th attempt (4.2% or 2/48). The scanning duration of L3/4 interspinous space and the posterior complex were 21.0 [IQR: 17.0, 32.0] secs and 11.0 [IQR: 5.0, 22.0] secs respectively. There is good correlation between the program recorded depth of the skin to posterior complex and clinician measured depth (r = 0.915). CONCLUSIONS: The automated spinal landmark identification program is able to provide assistance to needle insertion point identification in obese patients. There is good correlation between program recorded and clinician measured depth of the skin to posterior complex of dura mater. Future research may involve imaging algorithm improvement to assist with needle insertion guidance during neuraxial anesthesia. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov registry ( NCT03687411 ) on 22 Aug 2018.

A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain.

BACKGROUND: We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) analgesic infusion pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients' vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. METHODS: Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 h until assessment of patient satisfaction on the VPIA analgesic infusion pump. RESULTS: The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (< 95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 min. The median percentage time spent during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients' median [IQR] pain scores at rest and at movement after post-op 24 h were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 h was 12.5 ± 7.1 mg. All patients were satisfied with their experience with the VPIA analgesic infusion pump. CONCLUSIONS: The use of VPIA analgesic infusion pump, when integrated with continuous vital signs monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov registry (NCT02804022) on 28 Feb 2016.

The use of pre-operative virtual reality to reduce anxiety in women undergoing gynecological surgeries: a prospective cohort study.

BACKGROUND: Pre-operative anxiety is common and is associated with negative surgical outcomes. Virtual reality (VR) is a promising new technology that offers opportunities to modulate patient experience and cognition and has been shown to be associated with lower levels of anxiety. In this study, we investigated changes in pre-operative anxiety levels before and after using VR in patients undergoing minor gynecological surgery. METHODS: Patients who underwent elective minor gynecological surgeries in KK Women's and Children's hospital, Singapore were recruited. The VR intervention consisted of 10-min exposure via a headset loaded with sceneries, background meditation music and breathing exercises. For the primary outcome of pre-operative anxiety, patients were assessed at pre- and post-intervention using the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes of self-reported satisfaction scores and EuroQol 5-dimension 3-level (EQ-5D-3L) were also collected. RESULTS: Data analysis from 108 patients revealed that HADS anxiety scores were significantly reduced from 7.2 ± 3.3 pre-intervention to 4.6 ± 3.0 post-intervention (p < 0.0001). Furthermore, HADS depression scores were significantly reduced from 4.7 ± 3.3 pre-intervention to 2.9 ± 2.5 post-intervention (p < 0.0001). Eighty-two percent of the patients self-reported VR intervention as 'Good' or 'Excellent'. EQ-5D-3L showed significant changes in dimensions of 'usual activities' (p = 0.025), 'pain/discomfort' (p = 0.008) and 'anxiety/ depression' (p < 0.0001). CONCLUSIONS: For patients undergoing minor gynecological procedures, the VR intervention brought about a significant reduction in pre-operative anxiety. This finding may be clinically important to benefit patients with high pre-operative anxiety without the use of anxiolytics. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov registry ( NCT03685422 ) on 26 Sep 2018.

A novel approach to neuraxial anesthesia: application of an automated ultrasound spinal landmark identification.

BACKGROUND: Neuraxial procedures are commonly performed for therapeutic and diagnostic indications. Currently, they are typically performed via palpation-guided surface landmark. We devised a novel intelligent image processing system that identifies spinal landmarks using ultrasound images. Our primary aim was to evaluate the first attempt success rate of spinal anesthesia using landmarks obtained from the automated spinal landmark identification technique. METHODS: In this prospective cohort study, we recruited 100 patients who required spinal anesthesia for surgical procedures. The video from ultrasound scan image of the L3/4 interspinous space in the longitudinal view and the posterior complex in the transverse view were recorded. The demographic and clinical characteristics were collected and analyzed based on the success rates of the spinal insertion. RESULTS: Success rate (95%CI) for dural puncture at first attempt was 92.0% (85.0-95.9%). Median time to detection of posterior complex was 45.0 [IQR: 21.9, 77.3] secs. There is good correlation observed between the program-recorded depth and the clinician-measured depth to the posterior complex (r = 0.94). CONCLUSIONS: The high success rate and short time taken to obtain the surface landmark with this novel automated ultrasound guided technique could be useful to clinicians to utilise ultrasound guided neuraxial techniques with confidence to identify the anatomical landmarks on the ultrasound scans. Future research would be to define the use in more complex patients during the administration of neuraxial blocks. TRIAL REGISTRATION: This study was retrospectively registered on clinicaltrials.gov registry ( NCT03535155 ) on 24 May 2018.

Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial.

BACKGROUND: The obstetric airway is a significant cause of maternal morbidity and mortality. Endotracheal intubation is considered the standard of care but the laryngeal mask airway (LMA) has gained acceptance as a rescue airway and has been incorporated into the obstetric airway management guidelines. In this randomized controlled equivalence trial, we compared the Supreme LMA (SLMA) with endotracheal intubation (ETT) in managing the obstetric airway during cesarean section. METHODS: Parturients who underwent elective cesarean section under general anesthesia were randomized to receive either an SLMA or ETT as their airway device. Our primary outcome was first-attempt insertion success. Successful insertion was defined as adequate bilateral air entry with auscultation and the presence of end-tidal carbon dioxide on the capnogram. The first-attempt insertion success rate was compared using the Chi-Square test. Secondary outcomes included time-to-ventilation, seal pressure, ventilation/hemodynamic parameters, occurrence of clinical aspiration, fetal outcomes, and maternal side effects associated with the airway device. RESULTS: We recruited 920 parturients (460 SLMA, 460 ETT) who underwent elective cesarean section under general anesthesia. Patient characteristics were similar between the groups. First attempt success was similar (Odds Ratio--ORSLMA/ETT: 1.00 (95%CI: 0.25, 4.02), p = 1.0000). SLMA was associated with reduced time to effective ventilation (Mean Difference--MD -22.96; 95%CI: - 23.71, - 22.21 s) compared to ETT group (p <  0.0001). Ventilation parameters, maternal and fetal outcomes were similar between the groups, and there was no aspiration. CONCLUSIONS: SLMA could be an alternative airway management technique for a carefully selected low-risk obstetric population, with similar insertion success rates, reduced time to ventilation and less hemodynamic changes compared with ETT. Our findings are consistent with the airway guidelines in recommending the second-line use of LMA in the management of the obstetric airway. TRIAL REGISTRATION: The study was registered at http://www.clinicaltrials.gov , identifier: NCT01858467 , retrospectively registered. Date of registration: May 21, 2013.

Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme™ laryngeal mask airway in cesarean section.

BACKGROUND: Obstetric dfficult airway is a leading cause of maternal morbidity and mortality. The laryngeal mask airway (LMA) is often used as a rescue airway device after failed intubation, however, little is known about predictors of difficult LMA insertion, particularly in obstetrics. Since Mallampati scores of III/IV has been associated with difficult tracheal intubation, our present study aims to investigate if Mallampati score (MP) could predict airway outcomes for LMA use in obstetrics. METHODS: This prospective cohort study was performed at a single-center: Quanzhou Women's and Children's Hospital, Fujian Province, China. Five hundred and eighty-four parturients undergoing elective cesarean section under general anesthesia were recruited. The primary outcome was time to effective ventilation, and secondary outcomes included first attempt insertion success, seal pressure, ventilation and hemodynamic parameters, occurrence of clinical aspiration, and maternal and fetal outcomes. RESULTS: The parturients were classified into two groups based on MP of III/IV (High MP: 61) versus I/II (Low MP: 523). BMI was higher in the High MP group than in the Low MP group (mean (SD) 29.3 (7.0) vs 26.8 (3.1), p <  0.0001). There was no difference in maternal age, ASA status and gestational age. There was similar time to effective ventilation (mean (SD) High MP: 14.9 (4.5) vs Low MP: 15.7 (4.4) seconds, p = 0.2172), and first attempt success rate, seal pressure, and peak airway pressure. No clinical aspiration was noted. The incidence of blood on SLMA was higher in the High MP group than in Low MP (4 (6.6%) vs 4 (0.8%), p = 0.001). There was no difference in sore throat, voice hoarseness, maternal satisfaction and fetal outcomes. CONCLUSION: High MP was not associated with reduced SLMA airway outcomes in cesarean section under general anesthesia, but may increase the risk of blood found on SLMA upon removal. TRIAL REGISTRATION: This study was registered at http://www.clinicaltrials.gov , identifier: NCT02026882 , retrospectively registered. Date of registration: December 31, 2013.

Reducing breakthrough pain during labour epidural analgesia: an update.

PURPOSE OF REVIEW: Neuraxial techniques are the current gold standard for labour analgesia, but are associated with up to 25% incidence of breakthrough pain. In this review, we aim to update clinicians on the latest research pertaining to the optimization of neuraxial labour analgesia. RECENT FINDINGS: Attempts to improve the efficacy and reliability of epidural analgesia while minimizing adverse effects have resulted in the rising popularity of combined spinal epidural and the dural puncture epidural (DPE). Recent studies have focused on determining the safety, efficacy, and optimization of the DPE technique.Another research focus is on the development of individualized therapy in which patients may titrate their own labour analgesia according to their varying requirements, possibly augmented with computer-aided feedback systems and automated mandatory bolus techniques that automatically adjust drug delivery to the patients' analgesic requirements. The addition of a risk-stratification model based on maternal, anaesthetic, and obstetric factors will facilitate early institution of individualized therapy to forestall breakthrough pain in higher risk patients. SUMMARY: Recent advances in combined spinal epidural, DPE, automated mandatory bolus, and individualized therapies have advanced our goal of providing effective labour analgesia that is titrated to changing analgesic requirements during labour and delivery and reducing breakthrough pain.

Investigating determinants for patient satisfaction in women receiving epidural analgesia for labour pain: a retrospective cohort study.

BACKGROUND: Epidural analgesia is a popular choice for labour pain relief. Patient satisfaction is an important patient-centric outcome because it can significantly influence both mother and child. However, there is limited evidence in the correlations between clinical determinants and patient satisfaction. We aim to investigate clinical covariates that are associated with low patient satisfaction in parturients receiving labour neuraxial analgesia. METHODS: After institutional ethics approval was obtained, we conducted a retrospective cohort study using electronic and corresponding hardcopy records from 10,170 parturients receiving neuraxial analgesia between the periods of January 2012 to December 2013 in KK Women's and Children's Hospital in Singapore. Demographic, obstetric and anesthetic data were collected. The patient satisfaction scores on the neuraxial labour analgesia was reported by the parturient at 24 to 48 h post-delivery during the post-epidural round conducted by the resident and pain nurse. Parturients were stratified into one of three categories based on their satisfaction scores. Ordinal logistic regression models were used to identify potential covariates of patient dissatisfaction. RESULTS: 10,146 parturients were included into the study, of which 3230 (31.8%) were 'not satisfied', 3646 (35.9%) were 'satisfied', and 3270 (32.2%) were 'very satisfied'. Multivariable ordinal logistic regression analysis showed that instrument-assisted vaginal delivery (p = 0.0007), higher post-epidural pain score (p = 0.0016), receiving epidural catheter resiting (p <  0.0001), receiving neuraxial analgesia at a more advanced cervical dilation (p = 0.0443), multiparity (p = 0.0039), and post-procedure complications headache (p = 0.0006), backache (p <  0.0001), urinary retention (p = 0.0002) and neural deficit (p = 0.0297) were associated with patient dissatisfaction. Chinese, compared with other ethnicities (p = 0.0104), were more likely to be dissatisfied. CONCLUSIONS: Our study has identified several clinical determinants that were independent associated factors for low patient satisfaction. These covariates could be useful in developing a predictive model to detect at-risk parturients and undertake time-sensitive precautionary measures for better patient satisfaction.

Development and validation of a predictive risk factor model for epidural re-siting in women undergoing labour epidural analgesia: a retrospective cohort study.

BACKGROUND: Epidural catheter re-siting in parturients receiving labour epidural analgesia is distressing to the parturient and places them at increased complications from a repeat procedure. The aim of this study was to develop and validate a clinical risk factor model to predict the incidence of epidural catheter re-siting in labour analgesia. METHODS: The data from parturients that received labour epidural analgesia in our centre during 2014-2015 was used to develop a predictive model for epidural catheter re-siting during labour analgesia. Multivariate logistic regression analysis was used to identify factors that were predictive of epidural catheter re-siting. The forward, backward and stepwise variable selection methods were applied to build a predictive model, which was internally validated. The final multivariate model was externally validated with the data collected from 10,170 parturients during 2012-2013 in our centre. RESULTS: Ninety-three (0.88%) parturients in 2014-2015 required re-siting of their epidural catheter. The training data set included 7439 paturients in 2014-2015. A higher incidence of breakthrough pain (OR = 4.42), increasing age (OR = 1.07), an increased pain score post-epidural catheter insertion (OR = 1.35) and problems such as inability to obtain cerebrospinal fluid in combined spinal epidural technique (OR = 2.06) and venous puncture (OR = 1.70) were found to be significantly predictive of epidural catheter re-siting, while spontaneous onset of labour (OR = 0.31) was found to be protective. The predictive model was validated internally on a further 3189 paturients from the data of 2014-2015 and externally on 10,170 paturients from the data of 2012-2013. Predictive accuracy of the model based on C-statistic were 0.89 (0.86, 0.93) and 0.92 (0.88, 0.97) for training and internal validation data respectively. Similarly, predictive accuracy in terms of C-statistic was 0.89 (0.86, 0.92) based on 2012-2013 data. CONCLUSION: Our predictive model of epidural re-siting in parturients receiving labour epidural analgesia could provide timely identification of high-risk paturients required epidural re-siting.

Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial.

BACKGROUND: Hypotension is a common side effect of spinal anaesthesia during caesarean delivery and is associated with maternal and foetal adverse effects. We developed an updated double intravenous vasopressor automated (DIVA) system that administers phenylephrine or ephedrine based on continuous noninvasive haemodynamic monitoring using the Nexfin device. OBJECTIVE: The aim of our present study is to compare the performance and reliability of the DIVA system against Manual Vasopressor Bolus administration. DESIGN: A randomised, double-blind controlled trial. SETTING: Single-centre, KK Women's and Children's Hospital, Singapore. PATIENTS: Two hundred and thirty-six healthy women undergoing elective caesarean delivery under spinal anaesthesia. MAIN OUTCOME MEASURES: The primary outcome was the incidence of maternal hypotension. The secondary outcome measures were reactive hypertension, total vasopressor requirement and maternal and neonatal outcomes. RESULTS: The DIVA group had a significantly lower incidence of maternal hypotension, with 39.3% (46 of 117) patients having any SBP reading less than 80% of baseline compared with 57.5% (65 of 113) in the manual vasopressor bolus group (P = 0.008). The DIVA group also had fewer hypotensive episodes than the manual vasopressor bolus group (4.67 versus 7.77%; P < 0.0001). There was no difference in the incidence of reactive hypertension or the total vasopressor requirement. The DIVA group had less wobble in system performance. Maternal and neonatal outcomes were similar. CONCLUSION: The DIVA system achieved better control of maternal blood pressure after spinal anaesthesia than manual vasopressor bolus administration. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02277730.

A preliminary assessment of the LMA protector™ in non-paralysed patients.

BACKGROUND: The LMA Protector™ is the latest CE marked single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts. There are two ports (male, female ports) to provide suction in the laryngeal region and insertion of the gastric tube. The aim of our study is to assess the ease of use, airway quality, device positioning, airway leak and complications associated with initial clinical experience in LMA Protector™ usage. METHODS: This is an initial investigation of LMA Protector™ airway device. We conducted a preliminary assessment in the anaesthetised women who underwent minor gynaecological procedures with spontaneous ventilation in order to evaluate the performance of the airway device. RESULTS: Insertion was successful on first and second attempts in 23 (88.5%) and 3 (11.5%) respectively. Median [IQR (range)] insertion time was 19 [17-21(14-58)] seconds. Airway leak pressure was 25.5 [23-29(21-30] cmH2O. On fibreoptic examination via the device, vocal cords were visible in all 26 patients. There were no alternative airway use or airway manipulations required during maintenance of anaesthesia. Six patients had sore throat 24 h after procedures and there was no dysphagia or hoarseness. CONCLUSION: This pilot study of the LMA protector shows that the device is easily inserted with fast insertion time, providing a reliable and adequate airway seal. TRIAL REGISTRATION: Clinicaltrials.gov Registration NCT02531256 . Retrospectively registered on August 21, 2015.

Supreme™ laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study.

BACKGROUND: The Supreme™ laryngeal mask airway (SLMA) is a single-use LMA with double lumen design that allows separation of the respiratory and the alimentary tract, hence potentially reducing the gastric volume and risk of aspiration. The purpose of this prospective cohort study is to evaluate the the role of the SLMA as an airway technique for women undergoing category 2 and 3 Cesarean delivery under general anesthesia. METHODS: We recruited 584 parturients who underwent category 2 or 3 Cesarean delivery under general anesthesia, in which 193 parturients underwent category 2 and 391 parturients underwent category 3 Cesarean delivery. The primary outcome was insertion success rate at 1st attempt in SLMA insertion. The secondary outcomes included anaesthetic, obstetric outcomes and maternal side effects associated with airway device. RESULTS: The 1st attempt insertion success rate was 98.3%, while the overall insertion success rate was 100%. The mean (Standard deviation) time to effective ventilation was 15.6 (4.4) seconds. Orogastric tube insertion was successful at the 1st attempt in all parturients. There was no clinical evidence of aspiration or regurgitation. No episodes of hypoxemia, laryngospasm or bronchospasm were observed intra-operatively. The incidence of complications was low and with good maternal satisfaction reported. CONCLUSIONS: The SLMA could be an alternative effective airway in category 2 and 3 parturients emergency Cesarean Delivery under general anesthesia in a carefully-selected obstetric population. TRIAL REGISTRATION: Clinical Trials Registration: Clinicaltrials.gov Registration NCT02026882 . Registered on December 31, 2013.

The LMA Supreme™ in 700 parturients undergoing Cesarean delivery: an observational study.

BACKGROUND: The LMA Supreme™ (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. This observational study evaluated the role of the SLMA in parturients undergoing Cesarean delivery under general anesthesia. METHODS: Non-obese parturients with at least four hours of fasting and antacid prophylaxis scheduled for uncomplicated Cesarean delivery were recruited from June 2009 through May 2010 at the Quanzhou Women's and Children's Hospital, China. We recorded the number of SLMA insertion attempts, the time to effective ventilation, the incidence of aspiration, and other anesthetic and obstetric outcomes. Postoperatively, we noted the presence of blood on the SLMA, postoperative sore throat, and patient satisfaction. Analysis included comparison of results between parturients having elective and urgent Cesarean delivery. RESULTS: We recruited 700 parturients (576 elective, 124 urgent). Mean (standard deviation) body mass index was 25.6 (2.5) kg·m(-2). All SLMA insertions were successful, with 686 (98%) inserted on first attempt and a time to effective airway of 19.5 (3.9) sec. We maintained ventilation and oxygenation in all parturients with a good seal and there was no evidence of aspiration. Eighteen parturients (2.6%) had blood on the SLMA upon removal, 24 (3.4%) had sore throat, and patient satisfaction was 85 (7)%. These results were similar in elective and urgent cases. CONCLUSIONS: In a carefully selected group of parturients, the SLMA is a useful alternative to tracheal intubation for Cesarean delivery, providing effective ventilation and a low incidence of side effects or complications.

A comparison between remifentanil and meperidine for labor analgesia: a systematic review.

BACKGROUND: Remifentanil is an ultrashort-acting opioid with favorable pharmacokinetic properties that make it suitable as a labor analgesic. Although it crosses the placenta freely, it is eliminated quickly in the neonate by rapid metabolism and redistribution. We aimed to determine whether remifentanil compared with meperidine is effective in reducing pain scores in laboring parturients. Other effects on the mother, the labor process, and the neonate were also examined. METHODS: MEDLINE, CINAHL, Embase, Cochrane CENTRAL, and Maternity and Infant Care databases were searched without language restriction using multiple keywords for labor analgesia, remifentanil, and meperidine. Published abstracts from 5 key research meetings and references from retrieved articles were examined for additional studies. Randomized controlled trials in laboring parturients comparing remifentanil with meperidine were selected. Risk of bias was assessed using criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed for adequacy of sequence generation, allocation concealment, blinding, and completeness of follow-up. Data were extracted from each study using a standardized data collection form. The primary outcome was reduction in pain scores (visual analog scale [VAS], 0-100 mm). We also evaluated maternal side effects (sedation, oxygen desaturation, and bradypnea) and effects on the neonate (Apgar scores, umbilical cord pH, and Neurologic and Adaptive Capacity Scores). RESULTS: Seven studies (349 patients) were identified for inclusion; only 3 studies were suitable for quantitative synthesis in a meta-analysis (233 patients). We found that remifentanil reduces the mean VAS score at 1 hour by 25 mm more than meperidine (P < 0.001) (95% confidence interval = 19-31 mm). Limited conclusions can be made regarding the side-effect profile of remifentanil because of insufficient data. CONCLUSION: Compared with meperidine, remifentanil is superior in reducing mean VAS scores for labor pain after 1 hour.

Blockchain applications in health care for COVID-19 and beyond: a systematic review.

The COVID-19 pandemic has had a substantial and global impact on health care, and has greatly accelerated the adoption of digital technology. One of these emerging digital technologies, blockchain, has unique characteristics (eg, immutability, decentralisation, and transparency) that can be useful in multiple domains (eg, management of electronic medical records and access rights, and mobile health). We conducted a systematic review of COVID-19-related and non-COVID-19-related applications of blockchain in health care. We identified relevant reports published in MEDLINE, SpringerLink, Institute of Electrical and Electronics Engineers Xplore, ScienceDirect, arXiv, and Google Scholar up to July 29, 2021. Articles that included both clinical and technical designs, with or without prototype development, were included. A total of 85 375 articles were evaluated, with 415 full length reports (37 related to COVID-19 and 378 not related to COVID-19) eventually included in the final analysis. The main COVID-19-related applications reported were pandemic control and surveillance, immunity or vaccine passport monitoring, and contact tracing. The top three non-COVID-19-related applications were management of electronic medical records, internet of things (eg, remote monitoring or mobile health), and supply chain monitoring. Most reports detailed technical performance of the blockchain prototype platforms (277 [66·7%] of 415), whereas nine (2·2%) studies showed real-world clinical application and adoption. The remaining studies (129 [31·1%] of 415) were themselves of a technical design only. The most common platforms used were Ethereum and Hyperledger. Blockchain technology has numerous potential COVID-19-related and non-COVID-19-related applications in health care. However, much of the current research remains at the technical stage, with few providing actual clinical applications, highlighting the need to translate foundational blockchain technology into clinical use.

The Association Between Preoperative Pain Catastrophizing and Chronic Pain After Hysterectomy - Secondary Analysis of a Prospective Cohort Study.

PURPOSE: Hysterectomy is associated with a high incidence of chronic post-hysterectomy pain (CPHP). Pain catastrophizing, a negative cognitive-affective response to pain, is associated with various pain disorders but its role in CPHP is unclear. We aimed to determine the association of high preoperative pain catastrophizing with CPHP development and functional impairment 4 months after surgery. PATIENTS AND METHODS: Secondary analysis of a prospective cohort study of women undergoing abdominal/laparoscopic hysterectomy to investigate the association between high pain catastrophizing (pain catastrophizing scale, PCS≥20) with CPHP and associated functional impairment (defined as impairment with standing for ≥30 minutes, sitting for ≥30 minutes, or walking up or down stairs). CPHP and functional impairment were assessed via 4- and 6-month phone surveys. RESULTS: Of 216 patients, 72 (33.3%) had high PCS, with mean (SD) of 30.0 (7.9). In contrast, 144 (66.7%) patients had low PCS, with mean (SD) of 9.0 (4.7). At 4 months, 26/63 (41.3%) patients in the high PCS group developed CPHP, compared to 24/109 (22.0%) in the low PCS group. At 6 months, 14/53 (26.4%) high PCS patients developed CPHP, compared to 10/97 (10.3%) patients with low PCS. High PCS was independently associated with CPHP at 4 months (OR 2.49 [95% CI 1.27 to 4.89], p=0.0082) and 6 months (OR 3.12 [95% CI 1.28 to 7.64], p=0.0126) but was not associated with functional impairment. High PCS≥20, presence of evoked mechanical temporal summation (MTS), and history of abdominal/pelvic surgery predict CPHP at 4 months with area under the curve (AUC) of 0.69. Similarly, PCS≥20 and increasing MTS magnitude predicted CPHP at 6 months with AUC of 0.76. CONCLUSION: High PCS was independently associated with CPHP. Future studies should identify other CPHP associated factors to formulate a risk-prediction model and investigate the effectiveness of early intervention for pain catastrophizers in improving pain-related outcomes.