PaCO2 trajectories in mechanically ventilated patients with COVID-19: A population-based cohort study.

OBJECTIVE: To identify PaCO2 trajectories and assess their associations with mortality in critically ill patients with coronavirus disease 2019 (COVID-19) during the first and second waves of the pandemic in Denmark. DESIGN: A population-based cohort study with retrospective data collection. PATIENTS: All COVID-19 patients were treated in eight intensive care units (ICUs) in the Capital Region of Copenhagen, Denmark, between March 1, 2020 and March 31, 2021. MEASUREMENTS: Data from the electronic health records were extracted, and latent class analyses were computed based on up to the first 3 weeks of mechanical ventilation to depict trajectories of PaCO2 levels. Multivariable Cox regression analyses were used to calculate adjusted hazard ratios (aHRs) for Simplified Acute Physiology Score 3, sex and age with 95% confidence intervals (CIs) for death according to PaCO2 trajectories. MAIN RESULTS: In latent class trajectory models, including 25,318 PaCO2 measurements from 244 patients, three PaCO2 latent class trajectories were identified: a low isocapnic (Class I; n = 130), a high isocapnic (Class II; n = 80), as well as a progressively hypercapnic (Class III; n = 34) trajectory. Mortality was higher in Class II [aHR: 2.16 {1.26-3.68}] and Class III [aHR: 2.97 {1.63-5.40}]) compared to Class I (reference). CONCLUSION: Latent class analysis of arterial blood gases in mechanically ventilated COVID-19 patients identified distinct PaCO2 trajectories, which were independently associated with mortality.

Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial.

BACKGROUND: A key point in pathways for optimal rehabilitation and enhanced recovery is an effective postoperative multimodal pain treatment regimen. OBJECTIVE: To investigate the analgesic effects of transversus abdominis plane (TAP) block in conjunction with paracetamol and ibuprofen in patients undergoing laparoscopic colonic resection. DESIGN: Randomised placebo-controlled double-blind study. SETTING: Herlev University Hospital, Copenhagen, Denmark, from March 2010 to February 2013. PATIENTS: Eighty adult patients scheduled for elective laparoscopic colectomy. INTERVENTIONS: Bilateral TAP block with 20 ml of either ropivacaine or isotonic saline. MAIN OUTCOME MEASURES: Visual analogue scale (VAS) pain scores (0 to 100 mm) while coughing at 6 h after surgery (primary outcome). Secondary outcomes were area under the curve pain scores (2 to 24 h) at rest and while coughing, 24-h morphine consumption and incidence of nausea and vomiting. RESULTS: VAS pain scores at 6 h while coughing was not different between groups (median, interquartile range), TAP, 27 (11 to 45) mm vs. placebo, 33 (20 to 49) mm (P = 0.20). Total 24-h morphine consumption was reduced in the TAP block group vs. placebo group, 30 (15 to 41) mg vs. 43 (30 to 67) mg, respectively (P = 0.008). This difference was most pronounced in the first postoperative hours. The remaining outcomes did not differ between groups. CONCLUSION: TAP block used in combination with paracetamol and ibuprofen did not reduce pain after laparoscopic colonic surgery. However, we found a 30% reduction in opioid use, most marked in the early postoperative period. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01418144).

Augmenting health care failure modes and effects analysis with simulation.

This study explores whether simulation plays a role in health care failure mode and effects analysis (HFMEA); it does this by evaluating whether additional data are found when a traditional HFMEA is augmented with simulation. Two multidisciplinary teams identified vulnerabilities in a process by brainstorming, followed by simulation. Two means of adding simulation were investigated as follows: just simulating the process and interrupting the simulation between substeps of the process. By adding simulation to a traditional HFMEA, both multidisciplinary teams identified additional data that were relevant for deeper analysis. The study indicates that simulation has a role in HFMEA. Both ways of using simulation seemed feasible, and our results are not conclusive in selecting one over the other.

The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial.

CONTEXT: The analgesic effect of transversus abdominis plane (TAP) block after inguinal hernia repair is unclear. OBJECTIVE: The aim of this randomised and double-blind study was to evaluate the analgesic effect of a TAP block in patients scheduled for primary inguinal hernia repair. The TAP block was evaluated versus placebo and versus an active comparator (ilioinguinal block and wound infiltration). DESIGN: Randomised controlled trial. SETTING: Single centre trial. Study period from June 2010 to November 2011. PATIENTS: Adults (18 to 75 years) with American Society of Anesthesiologists' status 1-3 scheduled for primary inguinal hernia repair as day case surgery were included in the study. INTERVENTIONS: Ninety patients were allocated to one of three groups: group TAP, group infiltration (ilioinguinal nerve block and wound infiltration) and group placebo. MAIN OUTCOME MEASURES: The primary outcome measure was pain scores while coughing between group TAP and group placebo calculated as area under the curve for the first 24  h (AUC24 h). Secondary outcomes were pain scores while coughing and at rest, opioid consumption and side effects in groups TAP, infiltration and placebo. RESULTS: Visual analogue pain scores while coughing and at rest demonstrated no difference between groups. Pain scores in groups infiltration, TAP and placebo were 19 versus 22 versus 15  mm at rest (P = 1.00) and 37 versus 41 versus 37  mm while coughing (P = 1.00). Pain scores at 6 h (AUC6 h) were significantly lower in group infiltration than in group TAP (10 versus 25 mm at rest, P < 0.001; 17 versus 40  mm while coughing, P < 0.001), and than in group placebo (10 versus 20  mm at rest, P = 0.003; 17 versus 38  mm while coughing, P < 0.001). Median morphine consumption was lower in group infiltration than in group placebo (0 versus 5 mg, P < 0.003). No differences among groups were demonstrated for ketobemidone consumption or side effects. CONCLUSION: Ultrasound-guided TAP block did not reduce postoperative pain after inguinal hernia repair. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01052285. EudraCT number 2010-018403-29.

[General anaesthesia is used too frequently for caesarean section]. / Generel anæstesi anvendes for hyppigt ved akut sectio.

As general anaesthesia (GA) for caesarean section (CS) compared to regional anaesthesia (RA) can increase maternal risks, it has been suggested that 85% of all acute CS should be performed in RA. We observed whether anaesthesiologists at a Danish university hospital over a 4,5 year-period fulfilled this objective. Only five out of 27 anaesthesiologists had a rate of GA that was below 15%. Our results indicate that anaesthetising for CS routinely helps to keep the frequency of RA for CS above 85%. Further studies are necessary to investigate whether GA for CS is used according to recommendations.

The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial.

BACKGROUND: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2% of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels, impairing haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type crossmatch. So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. METHODS/DESIGN: In this randomised placebo-controlled double-blind multicentre trial, parturients with primary PPH are eligible following vaginal delivery in case of: manual removal of placenta (blood loss ≥ 500 ml) or manual exploration of the uterus after the birth of placenta (blood loss ≥ 1000 ml). Caesarean sections are also eligible in case of perioperative blood loss ≥ 1000 ml. The exclusion criteria are known inherited haemostatic deficiencies, prepartum treatment with antithrombotics, pre-pregnancy weight <45 kg or refusal to receive blood transfusion. Following informed consent, patients are randomly allocated to either early treatment with 2 g fibrinogen concentrate or 100 ml isotonic saline (placebo). Haemostatic monitoring with standard laboratory coagulation tests and thromboelastography (TEG, functional fibrinogen and Rapid TEG) is performed during the initial 24 hours.Primary outcome is the need for blood transfusion. To investigate a 33% reduction in the need for blood transfusion, a total of 245 patients will be included. Four university-affiliated public tertiary care hospitals will include patients during a two-year period. Adverse events including thrombosis are assessed in accordance with International Conference on Harmonisation (ICH) good clinical practice (GCP). DISCUSSION: A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to increased off-label use. The FIB-PPH trial is investigator-initiated and aims to provide an evidence-based platform for the recommendations of the early use of fibrinogen concentrate in PPH. TRIAL REGISTRATION: ClincialTrials.gov NCT01359878.

The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial.

BACKGROUND: Laparoscopic cholecystectomy is associated with postoperative pain of moderate intensity in the early postoperative period. Recent randomized trials have demonstrated the efficacy of transversus abdominis plane (TAP) block in providing postoperative analgesia after abdominal surgery. We hypothesized that a TAP block may reduce pain while coughing and at rest for the first 24 postoperative hours, opioid consumption, and opioid side effects in patients undergoing laparoscopic cholecystectomy in day-case surgery. METHODS: In this randomized, double-blind study, 80 patients undergoing laparoscopic cholecystectomy in our day-case surgery unit were allocated to receive either bilateral ultrasound-guided posterior TAP blocks (20 mL 0.5% ropivacaine) or placebo blocks. Postoperative pain treatment consisted of oral acetaminophen 1000 mg × 4, oral ibuprofen 400 mg × 3, IV morphine (0-2 hours postoperatively), and oral ketobemidone (2-24 hours postoperatively). The primary outcome was postoperative pain scores while coughing calculated as area under the curve for the first 24 postoperative hours (AUC/24 h). Secondary outcomes were pain scores at rest (AUC/24 h), opioid consumption, and side effects. Patients were assessed 0, 2, 4, 6, 8, and 24 hours postoperatively. Group-wise comparisons of visual analog scale (VAS) pain (AUC/24 h) were performed with the 2-sample t test. Morphine and ketobemidone consumption were compared with the Mann-Whitney test for unpaired data. Categorical data were analyzed using the χ(2) test. RESULTS: The primary outcome variable, VAS pain scores while coughing (AUC/24 h), was significantly reduced in the TAP versus the placebo group (P = 0.04); group TAP: 26 mm (SD 13) (weighted average level) versus group placebo: 34 (18) (95% confidence interval): 0.5-15 mm). VAS pain scores at rest (AUC/24 h) showed no significant difference between groups. Median morphine consumption (0-2 hours postoperatively) was 7.5 mg (interquartile range: 5-10 mg) in the placebo group compared with 5 mg (interquartile range: 0-5 mg) in the TAP group (P < 0.001). The odds ratio of a random patient in group TAP having less morphine consumption than a random patient in group placebo was P (group TAP < group placebo) = 0.26 (confidence interval: 0.15, 0.37) where 0.5 represents no difference between groups. There were no between-group differences in total ketobemidone consumption, levels of nausea and sedation, number of patients vomiting, or consumption of ondansetron. CONCLUSIONS: TAP block after laparoscopic cholecystectomy may have some beneficial effect in reducing pain while coughing and on opioid requirements, but this effect is probably rather small.

Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study.

CONTEXT: Elevated blood levels of lidocaine and ropivacaine have been described after transversus abdominis plane (TAP) block. OBJECTIVE: To investigate the pharmacokinetic profile of ropivacaine after bilateral TAP blocks. DESIGN: Prospective observational pharmacokinetic study. SETTING: University teaching hospital in Copenhagen, Denmark. PATIENTS: Twenty-one adult patients presenting for abdominopelvic surgery with bilateral TAP blocks were enrolled. PROCEDURES: Ultrasound-guided TAP blocks with bilateral injections of 20 ml ropivacaine 0.5% w/v (total dose 200 mg). Blood was sampled at 0, 10, 30 and 60 min after TAP blocks. MEASURES: Total and free peak blood concentrations (Cmax) of ropivacaine. RESULTS: Data were analysed from N = 18 patients. The median dose of ropivacaine was 2.7 mg kg(-1) (range: 1.9-4.2 mg kg(-1)). Median total ropivacaine concentrations were 1.0, 1.6 and 1.7 µg ml(-1) at 10, 30 and 60 min, respectively. Six patients (33%) had Cmax values above 2.2 µg ml(-1) and the highest concentration measured was 5.1 µg ml(-1). One patient had a 33% drop in mean arterial blood pressure. CONCLUSION: TAP blocks with bilateral injections of 20 ml ropivacaine 0.5% w/v gave rise to potentially toxic peak blood concentrations of total ropivacaine in one-third of the patients.

[Conditions for foreign doctors' clinical work assessed by Danish health care personnel, patients and foreign doctors]. / Forudsaetninger for udenlandske laegers kliniske arbejde--vurderet af dansk sundhedspersonale, patienter og udenlandske laeger.

INTRODUCTION: Many foreign doctors work in Danish hospitals. This study concerns the opportunities available to and difficulties encountered by these doctors. MATERIALS AND METHODS: A questionnaire concerning guidance available to foreign doctors, their linguistic and professional competence and their cultural backgrounds was sent to foreign doctors, to Danish doctors, to Danish nurses, and to patients in Greater Copenhagen. A total of 1539 questionnaires were sent. RESULTS: 49-57% in each group replied. The majority of both foreign doctors and Danish doctors found that introductory guidance was adequate, but nurses thought otherwise. A large majority of Danish personnel (78-89%) had experienced that they themselves or patients could not understand a foreign doctor. A lesser number of foreign doctors (27-33%) had the same experience with Danish personnel or patients. Foreign doctors' language difficulties gave rise to feelings of insecurity and doubts about professional competence in both Danish personnel and patients (53-69%). Danish personnel estimate that European Union (EU) doctors' professional competence is equal to Danish doctors' professional competence, while non-EU foreign doctors are not so highly esteemed. 90% of patients are of the opinion that foreign doctors are professionally competent. Cultural background can influence clinical practice in the opinion of 50% of Danish personnel and 42% of foreign doctors. CONCLUSION: Insufficient communication is the biggest challenge for foreign doctors, and can influence the evaluation of their professional competence. Cultural differences may influence foreign doctors' cooperation with Danish personnel. Patients are satisfied with treatment given by foreign doctors.