A Medicoeconomic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: Protocol for a Randomized Controlled Trial.

BACKGROUND: The number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients' pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery. OBJECTIVE: The objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways. METHODS: This study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l'Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis. RESULTS: Results of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways. CONCLUSIONS: We believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44006.

Pre-operative peripheral intravenous cannula insertion failure at the first attempt in adults: Development of the VENSCORE predictive scale and identification of risk factors.

STUDY OBJECTIVE: Our objective was to develop a clinical scale (the VENSCORE) to predict pre-operative peripheral intravenous cannula (PIVC) insertion failure at the first attempt in adults. DESIGN: This was a prospective multicenter cohort study that included internal validation with bootstrapping. SETTING: The operating rooms of 14 hospitals in southern France from June 2016 to June 2018. PATIENTS: Consecutive adult patients aged 18 years or older were recruited upon arrival to the operating room, regardless of American Society of Anaesthesiology (ASA) physical status. INTERVENTIONS: PIVC insertion on arrival to the OR. MEASUREMENTS: PIVC insertion failure at the first attempt was the outcome of interest. Data collected included the number of PIVC insertion attempts and potential predictors of the risk of failure (including pre-operative patient characteristics and data relative to the procedure). Uni- and multivariable logistic analyses were performed. Based on these results, the VENSCORE scale was developed to predict the risk of failure of the first PIVC insertion. MAIN RESULTS: In total, 3394 patients were included, and 27 were excluded because of protocol violations. The PIVC insertion failure rate at the first attempt was 20.3%. Based on multivariable analysis, a history of difficult PIVC insertions, high-risk surgery, poor vein visibility, and moderate to poor vein palpability were identified as risk factors for insertion failure at the first attempt. The area under the curve of the predictive model was 0.82 (95% confidence interval: 0.80-0.84). A VENSCORE value of 0 points was associated with a failure rate of 7%, versus 97% for a score of 6. CONCLUSIONS: The four-item VENSCORE scale could be useful for prospectively identifying adults at risk of first PIVC insertion attempt failure.

Pain evaluation after day-surgery using a mobile phone application.

INTRODUCTION: Few studies assess postoperative outcomes after discharge in the ambulatory setting. The aim of this study was to investigate postoperative pain and adverse effects at 24 h and at 7 days after day surgery using an e-health follow-up smartphone-based application named SATELIA®. MATERIALS AND METHODS: This retrospective, observational and monocentric cohort study was conducted at the University Hospital of Bordeaux. All eligible patients for SATELIA® follow-up between May 2018 and June 2019 were screened for the analysis. Data were extracted from two databases. Those with a missing primary outcome were excluded from the analysis. The main outcome was the worst pain score on POD 1, self-reported via SATELIA®. The secondary outcomes were the incidence of adverse effects on POD1, as well as the worst pain score and adverse effects on POD7. Quantitative data were reported by the median (IQR) and categorical data were presented as absolute numbers (%). RESULTS: A total of 2283 patients were screened for analysis, from which 592 were excluded due to missing data for the main outcome; 1691 patients were thus finally included. The median worst pain score at POD 1 was 3.0 (1.0-5.0); 35.5% (n = 601/1691) and 29.1% (n = 492/1691) of the patients reported moderate-to-severe pain at POD1 and POD7, respectively. CONCLUSION: This retrospective study shows that 35.5% of patients experience moderate-to-severe pain after day surgery. Even if SATELIA® should be further developed and evaluated, it also demonstrates the interest of using phone based software to follow patients after discharge and ensure a better personalised management.

[PECS I block for postoperative analgesia in patients undergoing breast augmentation surgery: a randomized double-blind placebo-controlled study]. / Bloqueio PECS I para analgesia pós­operatória em pacientes submetidos a mamoplastia de aumento: estudo randomizado, duplo­cego, controlado por placebo.

BACKGROUND AND OBJECTIVES: PECS I block was first described for surgery involving the pectoralis muscles. No randomized clinical trial has been conducted on surgeries that directly involve these muscles, such as subpectoral breast augmentation. We hypothesized that PECS I block would decrease pain in the postoperative period in this population. METHODS: This was a randomized, double-blind, placebo-controlled trial in women undergoing subpectoral breast augmentation surgery. PECS I block was performed using 0.4 mL.kg-1 of 0.9% saline on one side and bupivacaine (0.25%) on the other side, each patient being her own control. Numeric Rating Scale (NRS) pain scores (0-10) were measured at rest and during movement. The primary outcome was pain score at rest 30 minutes after arrival in the PACU. To detect a clinically significant difference of 50% in pain reduction, 14 volunteers were enrolled (power of 90% and alpha<0.05). RESULTS: In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side. In the bupivacaine group, pain scores at rest at 5, 30 and 60 minutes and 24 hours were 4.89 (4.23-5.56; mean 95% CI), 3.75 (3.13-4.37), 3.79 (2.93-4.64), and 2.29 (1.56-3.01), respectively, whereas in the placebo group, they were 4.96 (4.32-5.60), 4.00 (3.50-4.49), 3.93 (3.12-4.73), and 2.29 (1.56-3.01), respectively. CONCLUSIONS: PECS I block in patients undergoing breast augmentation surgery does not provide better pain relief than placebo. Therefore, the indications for PECS I block in breast augmentation surgery should be reconsidered.

EQSAR: A national survey of sleep duration among French Anaesthesiologists and Intensivists.

INTRODUCTION: The US National Sleep Foundation recommends more than 7 hours of sleep per night for adults. Anaesthesiologists and intensivists (AI) are at high risk of short sleep time. The aim of this present survey was to assess the sleep duration of French AI and to identify independent factors related to a sleep time less than the recommended 7 hours. METHODS: This prospective observational study was conducted between April and June 2018 and included 6,210 French AI with night-work obligations. The primary outcome variable was sleep duration strictly inferior to 7 hours per night. The covariables included in the multivariable model were selected after the univariate analysis, with those with a p < 0.05 included in the final model. RESULTS: Of the 6,210 AI, 3,699 responded to the survey, and 2,483 were included in the analysis. Of the 2,483 responders, 1,533 (61.7%) reported sleep duration strictly less than 7 hours per night. After the multivariate analysis, the following risk factors were independently associated with sleep duration strictly under 7 hours: age (OR: 1.28 ; IC [1.19 - 1.37]), more than 5 on-call shifts per month, (OR: 1.41 ; IC [1.30 - 1.50]), active smoking (OR: 1.37 ; IC [1.07 - 1.75]), and screen consultation at bedtime (OR: 1.85 ; IC [1.31 - 2.62]). CONCLUSION: This study gives a recent overview of sleep time and quality of French AI. It could be a useful tool for monitoring sleep disorders among the practitioners and their impact on quality of life.

PECS I block for postoperative analgesia in patients undergoing breast augmentation surgery: a randomized double-blind placebo-controlled study / Bloqueio PECS I para analgesia pós-operatória em pacientes submetidos a mamoplastia de aumento: estudo randomizado, duplo-cego, controlado por placebo

Abstract Background and objectives: PECS I block was first described for surgery involving the pectoralis muscles. No randomized clinical trial has been conducted on surgeries that directly involve these muscles, such as subpectoral breast augmentation. We hypothesized that PECS I block would decrease pain in the postoperative period in this population. Methods: This was a randomized, double-blind, placebo-controlled trial in women undergoing subpectoral breast augmentation surgery. PECS I block was performed using 0.4 mL.kg-1 of 0.9% saline on one side and bupivacaine (0.25%) on the other side, each patient being her own control. Numeric Rating Scale (NRS) pain scores (0 - 10) were measured at rest and during movement. The primary outcome was pain score at rest 30 minutes after arrival in the PACU. To detect a clinically significant difference of 50% in pain reduction, 14 volunteers were enrolled (power of 90% and alpha < 0.05). Results: In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side. In the bupivacaine group, pain scores at rest at 5, 30 and 60 minutes and 24 hours were 4.89 (4.23 - 5.56; mean 95% CI), 3.75 (3.13 - 4.37), 3.79 (2.93 - 4.64), and 2.29 (1.56 - 3.01), respectively, whereas in the placebo group, they were 4.96 (4.32 - 5.60), 4.00 (3.50 - 4.49), 3.93 (3.12 - 4.73), and 2.29 (1.56 - 3.01), respectively. Conclusions: PECS I block in patients undergoing breast augmentation surgery does not provide better pain relief than placebo. Therefore, the indications for PECS I block in breast augmentation surgery should be reconsidered.

Resumo Justificativa e objetivos: O bloqueio PECS I foi descrito pela primeira vez para cirurgia envolvendo os músculos peitorais. Nenhum estudo clínico randomizado foi realizado em procedimentos envolvendo diretamente os músculos peitorais, como a mamoplastia de aumento submuscular. Nossa hipótese foi de que o bloqueio PECS I diminuiria a dor pós-operatória nessa população. Método: Realizamos estudo randomizado, duplo-cego, controlado por placebo em mulheres submetidas à mamoplastia de aumento submuscular. Realizamos o bloqueio PECS I com 0,4 mL.kg-1 de solução salina a 0,9% de um lado e bupivacaína (0,25%) do outro lado, sendo cada paciente seu próprio controle. Os escores da Escala de Avaliação Numérica (EAN) de dor (0 - 10) foram obtidos em repouso e durante movimento. O desfecho primário foi o escore de dor em repouso 30 minutos após a chegada à SRPA. Para detectar uma diferença clinicamente significante de 50% na redução da dor, 14 voluntárias foram incluídas (poder de 90% e alfa < 0,05). Resultados: Na SRPA, três pacientes não apresentaram diferença na dor entre os lados, cinco relataram menos dor no lado do placebo e seis, menos dor no lado da bupivacaína. No grupo bupivacaína, os escores de dor em repouso aos 5, 30 e 60 minutos e 24 horas foram 4,89 (4,23 - 5,56; IC médio 95%), 3,75 (3,13 - 4,37), 3,79 (2,93 - 4,64) e 2,29 (1,56 - 3,01), respectivamente, enquanto no grupo placebo foram 4,96 (4,32 - 5,60), 4,00 (3,50 - 4,49), 3,93 (3,12 - 4,73) e 2,29 (1,56 - 3,01), respectivamente. Conclusões: O bloqueio PECS I em pacientes submetidas a mamoplastia de aumento não oferece melhor alívio da dor do que o placebo. Portanto, as indicações para bloqueio de PECS I na cirurgia de aumento de mama devem ser reconsideradas.

Pectoral nerves I block is associated with a significant motor blockade with no dermatomal sensory changes: a prospective volunteer randomized-controlled double-blind study.

PURPOSE: The pectoral nerves (PECS) I block, first described in 2011 for surgery involving the pectoralis muscle, has principally been used for breast cancer surgery. No formal evaluation of its differential motor- and sensory-blocking abilities has been reported. We hypothesize that the PECS I block will produce a motor block of the pectoralis muscles with diminished upper limb adduction strength as measured with a handheld dynamometer. METHODS: We conducted a PECS I block in a randomized placebo-controlled trial in six healthy subjects who received 0.4 mL·kg-1 of 0.9% saline (placebo) on one side and bupivacaine (0.25% with 1:400 000 epinephrine) on the other. We measured both upper limb adduction strength with a dynamometer and sensory skin levels over the thorax. RESULTS: The mean (standard deviation [SD]) adductor strength evaluated before the block was 119.4 (20.7) Newtons (N). After the PECS I block with bupivacaine, the mean (SD) strength of 54.2 (16.3) N was compared with 116.0 (30.4) N in the placebo group (difference in means 61.8 N; 95% confidence interval [CI], 27.8 to 95.8 N; P = 0.005), showing a 54.6% (95% CI, 43.6 to 65.6%) reduction in adductor strength. There was no difference in dermatomal skin sensory testing between the placebo and bupivacaine sides. CONCLUSIONS: This study shows that a PECS I block produces motor blockade as shown by reduced upper limb adductor strength without any overlying dermatomal sensory loss. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT03040167) 2 February 2017.

Anticoagulation Obtained below the Arterial Clamp Using a Single Fixed Bolus of Heparin in Vascular Surgery: A Pilot Study.

BACKGROUND: No clear recommendations exist regarding the optimal dosing of unfractionated heparin (UFH) during vascular surgery. Moreover, little is known about the effect of the UFH bolus downstream of the arterial clamp, where stasis and inflammation can possibly alter the anticoagulation obtained. METHODS: The aim of our prospective observational study was to assess anticoagulation below the arterial clamp and its clinical impact on the quality of revascularization. Thirty-six patients American Society of Anaesthesiologists physical status (ASA) grade I-III undergoing open revascularization surgeries were included. A baseline activated coagulation time (ACT) was obtained. Thirty minutes after a single bolus of 5,000 units of UFH, we measured an upstream ACT via a radial arterial catheter and an ACT below the arterial clamp via surgeon sampling. The quality of revascularization was assessed with preoperative and postoperative ankle-brachial and toe-brachial indexes (TBIs). RESULTS: The upstream postheparin ACT was significantly higher than the downstream postheparin ACT, with a mean difference of 24.3 sec (P < 0.0001). In 7 patients, the downstream ACT was lower than the baseline ACT. The upstream and downstream heparin concentrations were similar. There was no relationship between the downstream ACT and either ankle-brachial index improvement (28 patients, P = 0.51) or TBI improvement (27 patients, P = 0.21). CONCLUSIONS: Our study demonstrates a significant difference between the ACT above and below the arterial clamp without any clinical impact of this possibly insufficient anticoagulation. Further investigations are warranted to determine the optimal dose of UFH in vascular surgery. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02477072.

Postoperative awake paralysis in the intensive care unit after cardiac surgery due to residual neuromuscular blockade: a case report and prospective observational study.

PURPOSE: We report a case of awake paralysis due to residual neuromuscular blockade (NMB) in the intensive care unit (ICU) in a patient following fast-track cardiac surgery. As a result of this case, we performed a prospective quality assurance audit to investigate the incidence of residual paralysis in the ICU in a similar population of cardiac surgery patients. CLINICAL FEATURES AND AUDIT METHODS: A 73-yr-old woman (69 kg) underwent coronary artery bypass surgery under anesthesia induced with intravenous sufentanil 25 µg, midazolam 5 mg, ketamine 25 mg, and rocuronium 100 mg (followed by two additional 50-mg doses during surgery) and maintained with sevoflurane. Postoperatively in the ICU, the patient was initially sedated with propofol (50 mg·hr(-1)) but failed to awaken 90 min after its cessation. As train-of-four neurostimulation showed residual paralysis, she was re-sedated. Neostigmine 3 mg and glycopyrrolate 0.6 mg were administered, and she was extubated 30 min later. During this episode of residual paralysis, the patient was conscious and reported explicit memory of the events. She was discharged on day 7 without psychological distress related to her postoperative awake paralysis. We subsequently performed a prospective audit in 50 consecutive patients to determine the timing of NMB dosing and to quantify the incidence of residual paralysis after fast-track cardiac surgery. RESULTS: Of the 50 patients studied, 24 (48%) had received an NMB during the last hour of surgery and 33 (66%) had evidence of residual paralysis during the immediate postoperative period. CONCLUSION: Postoperative residual paralysis after fast-track cardiac surgery was common in our institution and likely contributed to the reported case of postoperative awake paralysis. We suggest that an NMB not be administered after intubation in fast-track patients. If given, however, it must be well communicated to the ICU team upon ICU admission. We further recommend routine assessment of neuromuscular function before sedation is weaned prior to extubation.