Dataset Information

Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit.

ABSTRACT: Intensive care unit patients undergoing mechanical ventilation have traditionally been sedated to make them comfortable and to avoid pain and anxiety. However, this may lead to prolonged mechanical ventilation and a longer length of stay.The aim of this retrospective study was to explore whether different sedation regimens influence the course and duration of the weaning process.Intubated adult patients (n = 152) from 15 general intensive care units in Sweden were mechanically ventilated for ? 24 h. Patients were divided into three groups according to the sedative(s) received during the weaning period (i.e. from being assessed as 'fit for weaning' until extubation): dexmedetomidine alone (DEX group, n = 32); standard of care with midazolam and/or propofol (SOC group, n = 67); or SOC plus dexmedetomidine (SOCDEX group, n = 53).Patients receiving dexmedetomidine alone were weaned more rapidly than those in the other groups despite spending longer time on mechanical ventilation prior to weaning. Anxiety during weaning was present in 0, 9 and 24% patients in the DEX, SOC and SOCDEX groups, respectively. Anxiety after extubation was present in 41, 20 and 34% in the DEX, SOC and SOCDEX groups, respectively. Delirium during weaning was present in 1, 2 and 1 patient in the DEX, SOC and SOCDEX groups, respectively. Delirium at ICU discharge was present in 1, 0 and 3 patients in the DEX, SOC and SOCDEX groups, respectively. Few patients fulfilled criteria for post-traumatic stress disorder.Dexmedetomidine, used as a single sedative, may have contributed to a shorter weaning period than SOC or SOCDEX. Patients who received dexmedetomidine-only sedation tended to report better health-related quality of life than those receiving other forms of sedation.

SUBMITTER: Nunes SL

PROVIDER: S-EPMC5951865 | biostudies-other | 2018 Jun

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit.

Nunes Silvia L SL Forsberg Sune S Blomqvist Hans H Berggren Lars L Sörberg Mikael M Sarapohja Toni T Wickerts Carl-Johan CJ

Clinical drug investigation 20180601 6

<h4>Background</h4>Intensive care unit patients undergoing mechanical ventilation have traditionally been sedated to make them comfortable and to avoid pain and anxiety. However, this may lead to prolonged mechanical ventilation and a longer length of stay.<h4>Objective</h4>The aim of this retrospective study was to explore whether different sedation regimens influence the course and duration of the weaning process.<h4>Patients and methods</h4>Intubated adult patients (n = 152) from 15 general i ...[more]

PMID: 29502195

Similar Datasets

Project description:ObjectiveTo investigate whether protocol-directed weaning in neurocritical patients would reduce the rate of extubation failure (as a primary outcome) and the associated complications (as a secondary outcome) compared with conventional weaning.MethodsA quasi-experimental study was conducted in a medical-surgical intensive care unit from January 2016 to December 2018. Patients aged 18 years or older with an acute neurological disease who were on mechanical ventilation > 24 hours were included. All patients included in the study were ready to wean, with no or minimal sedation, Glasgow coma score ≥ 9, spontaneous ventilatory stimulus, noradrenaline ≤ 0.2μgr/kg/ minute, fraction of inspired oxygen ≤ 0.5, positive end-expiratory pressure ≤ 5cmH2O, maximal inspiratory pressure < -20cmH2O, and occlusion pressure < 6cmH2O.ResultsNinety-four of 314 patients admitted to the intensive care unit were included (50 in the Intervention Group and 44 in the Control Group). There was no significant difference in spontaneous breathing trial failure (18% in the Intervention Group versus 34% in the Control Group, p = 0.12). More patients in the Intervention Group were extubated than in the Control Group (100% versus 79%, p = 0.01). The rate of extubation failure was not signifiantly diffrent between the groups (18% in the Intervention Group versus 17% in the Control Group; relative risk 1.02; 95%CI 0.64 - 1.61; p = 1.00). The reintubation rate was lower in the Control Group (16% in the Intervention Group versus 11% in the Control Group; relative risk 1.15; 95%CI 0.74 - 1.82; p = 0.75). The need for tracheotomy was lower in the Intervention Group [4 (8%) versus 11 (25%) in the Control Group; relative risk 0.32; 95%CI 0.11 - 0.93; p = 0.04]. At Day 28, the patients in the Intervention Group had more ventilator-free days than those in the Control Group [28 (26 - 28) days versus 26 (19 - 28) days; p = 0.01]. The total duration of mechanical ventilation was shorter in the Intervention Group than in the Control Group [5 (2 - 13) days versus 9 (3 - 22) days; p = 0.01]. There were no diffrences in the length of intensive care unit stay, 28-day free from mechanical ventilation, hospital stay or 90-day mortality.ConclusionConsidering the limitations of our study, the application of a weaning protocol for neurocritical patients led to a high percentage of extubation, a reduced need for tracheotomy and a shortened duration of mechanical ventilation. However, there was no reduction in extubation failure or the 28-day free of from mechanical ventilation compared with the Control Group.ClinicalTrials.gov Registry: NCT03128086.

Project description:IntroductionThis randomised, open-label, multicentre study compared the safety and efficacy of an analgesia-based sedation regime using remifentanil with a conventional hypnotic-based sedation regime in critically ill patients requiring prolonged mechanical ventilation for up to 10 days.MethodsOne hundred and five randomised patients received either a remifentanil-based sedation regime (initial dose 6 to 9 microg kg(-1) h(-1) (0.1 to 0.15 microg kg(-1) min(-1)) titrated to response before the addition of midazolam for further sedation (n = 57), or a midazolam-based sedation regime with fentanyl or morphine added for analgesia (n = 48). Patients were sedated to an optimal Sedation-Agitation Scale (SAS) score of 3 or 4 and a pain intensity (PI) score of 1 or 2.ResultsThe remifentanil-based sedation regime significantly reduced the duration of mechanical ventilation by more than 2 days (53.5 hours, P = 0.033), and significantly reduced the time from the start of the weaning process to extubation by more than 1 day (26.6 hours, P < 0.001). There was a trend towards shortening the stay in the intensive care unit (ICU) by 1 day. The median time of optimal SAS and PI was the same in both groups. There was a significant difference in the median time to offset of pharmacodynamic effects when discontinuing study medication in patients not extubated at 10 days (remifentanil 0.250 hour, comparator 1.167 hours; P < 0.001). Of the patients treated with remifentanil, 26% did not receive any midazolam during the study. In those patients that did receive midazolam, the use of remifentanil considerably reduced the total dose of midazolam required. Between days 3 and 10 the weighted mean infusion rate of remifentanil remained constant with no evidence of accumulation or of a development of tolerance to remifentanil. There was no difference between the groups in SAS or PI score in the 24 hours after stopping the study medication. Remifentanil was well tolerated.ConclusionAnalgesia-based sedation with remifentanil was well tolerated; it reduces the duration of mechanical ventilation and improves the weaning process compared with standard hypnotic-based sedation regimes in ICU patients requiring long-term ventilation for up to 10 days.

Project description:BackgroundCiprofol (HSK3486; Haisco Pharmaceutical Group Co., Ltd., Chengdu, China), developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy characteristics as propofol when applicated as continuous intravenous infusion for 12 h maintenance sedation in a previous phase 1 trial. The phase 2 trial was designed to investigate the safety, efficacy, and pharmacokinetic characteristics of ciprofol for sedation of patients undergoing mechanical ventilation.MethodsIn this multicenter, open label, randomized, propofol positive-controlled, phase 2 trial, 39 Chinese intensive care unit patients receiving mechanical ventilation were enrolled and randomly assigned to a ciprofol or propofol group in a 2:1 ratio. The ciprofol infusion was started with a loading infusion of 0.1-0.2 mg/kg for 0.5-5.0 min, followed by an initial maintenance infusion rate of 0.30 mg·kg -1 ·h -1 , which could be adjusted to an infusion rate of 0.06 to 0.80 mg·kg -1 ·h -1 , whereas for propofol the loading infusion dose was 0.5-1.0 mg/kg for 0.5-5.0 min, followed by an initial maintenance infusion rate of 1.50 mg·kg -1 ·h -1 , which could be adjusted to 0.30-4.00 mg·kg -1 ·h -1 to achieve -2 to +1 Richmond Agitation-Sedation Scale sedation within 6-24 h of drug administration.ResultsOf the 39 enrolled patients, 36 completed the trial. The median (min, max) of the average time to sedation compliance values for ciprofol and propofol were 60.0 (52.6, 60.0) min and 60.0 (55.2, 60.0) min, with median difference of 0.00 (95% confidence interval: 0.00, 0.00). In total, 29 (74.4%) patients comprising 18 (69.2%) in the ciprofol and 11 (84.6%) in the propofol group experienced 86 treatment emergent adverse events (TEAEs), the majority being of severity grade 1 or 2. Drug- and sedation-related TEAEs were hypotension (7.7% vs. 23.1%, P = 0.310) and sinus bradycardia (3.8% vs. 7.7%, P = 1.000) in the ciprofol and propofol groups, respectively. The plasma concentration-time curves for ciprofol and propofol were similar.Conclusionsciprofol is comparable to propofol with good tolerance and efficacy for sedation of Chinese intensive care unit patients undergoing mechanical ventilation in the present study setting.Trial registrationClinicalTrials.gov, NCT04147416.

Project description:ImportanceThere is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit.ObjectiveTo determine if a sedation and ventilator liberation protocol intervention reduces the duration of invasive mechanical ventilation in infants and children anticipated to require prolonged mechanical ventilation.Design, setting, and participantsA pragmatic multicenter, stepped-wedge, cluster randomized clinical trial was conducted that included 17 hospital sites (18 pediatric intensive care units) in the UK sequentially randomized from usual care to the protocol intervention. From February 2018 to October 2019, 8843 critically ill infants and children anticipated to require prolonged mechanical ventilation were recruited. The last date of follow-up was November 11, 2019.InterventionsPediatric intensive care units provided usual care (n = 4155 infants and children) or a sedation and ventilator liberation protocol intervention (n = 4688 infants and children) that consisted of assessment of sedation level, daily screening for readiness to undertake a spontaneous breathing trial, a spontaneous breathing trial to test ventilator liberation potential, and daily rounds to review sedation and readiness screening and set patient-relevant targets.Main outcomes and measuresThe primary outcome was the duration of invasive mechanical ventilation from initiation of ventilation until the first successful extubation. The primary estimate of the treatment effect was a hazard ratio (with a 95% CI) adjusted for calendar time and cluster (hospital site) for infants and children anticipated to require prolonged mechanical ventilation.ResultsThere were a total of 8843 infants and children (median age, 8 months [interquartile range, 1 to 46 months]; 42% were female) who completed the trial. There was a significantly shorter median time to successful extubation for the protocol intervention compared with usual care (64.8 hours vs 66.2 hours, respectively; adjusted median difference, -6.1 hours [interquartile range, -8.2 to -5.3 hours]; adjusted hazard ratio, 1.11 [95% CI, 1.02 to 1.20], P = .02). The serious adverse event of hypoxia occurred in 9 (0.2%) infants and children for the protocol intervention vs 11 (0.3%) for usual care; nonvascular device dislodgement occurred in 2 (0.04%) vs 7 (0.1%), respectively.Conclusions and relevanceAmong infants and children anticipated to require prolonged mechanical ventilation, a sedation and ventilator liberation protocol intervention compared with usual care resulted in a statistically significant reduction in time to first successful extubation. However, the clinical importance of the effect size is uncertain.Trial registrationisrctn.org Identifier: ISRCTN16998143.

Dataset Information

Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit.

Publications

Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets