Dataset Information

The Feasibility of Implementing Targeted SEDation in Mechanically Ventilated Emergency Department Patients: The ED-SED Pilot Trial.

ABSTRACT:

Objectives

Deep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial.

Design

Pragmatic, multicenter ( n = 3), prospective before-after pilot and feasibility trial.

Setting

The ED and ICUs at three medical centers.

Patients

Consecutive, adult mechanically ventilation ED patients.

Interventions

An educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome).

Measurements and main results

Sedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of -3 to -5 or a Sedation-Agitation Scale of 1-3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% ( p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group ( p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both.

Conclusions

This pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.

SUBMITTER: Fuller BM

PROVIDER: S-EPMC9288529 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

The Feasibility of Implementing Targeted SEDation in Mechanically Ventilated Emergency Department Patients: The ED-SED Pilot Trial.

Fuller Brian M BM Roberts Brian W BW Mohr Nicholas M NM Faine Brett B Drewry Anne M AM Wessman Brian T BT Ablordeppey Enyo E Pappal Ryan D RD Stephens Robert J RJ Sewatsky Thomas T Cho Nicholas S NS Yan Yan Y Kollef Marin H MH Carpenter Christopher R CR Avidan Michael S MS

Critical care medicine 20220411 8

<h4>Objectives</h4>Deep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient ...[more]

PMID: 35404327

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Project description:IntroductionSedation is a cornerstone therapy in the management of patients receiving mechanical ventilation and is highly influential on outcome. Early sedation depth appears especially influential, as early deep sedation is associated with worse outcome when compared with light sedation. Our research group has shown that patients receiving mechanical ventilation in the emergency department (ED) are exposed to deep sedation commonly, and ED sedation depth is impactful on intensive care unit (ICU) care and clinical outcomes. While extensive investigation has occurred for patients in the ICU, comparatively little data exist from the ED. Given the influence that ED sedation seems to carry, as well as a lack of ED-based sedation trials, there is significant rationale to investigate ED-based sedation as a means to improve outcome.Methods and analysisThis is a multicentre (n=3) prospective, before-and-after pilot trial examining the feasibility of implementing targeted sedation in the immediate postintubation period in the ED. A cohort of 344 patients receiving mechanical ventilation in ED will be included. Feasibility outcomes include: (1) participant recruitment; (2) proportion of Richmond Agitation-Sedation Scale (RASS) scores in the deep sedation range; (3) reliability (agreement) of RASS measurements performed by bedside ED nurses; and (4) adverse events. The proportion of deep sedation measurements before and after the intervention will be compared using the χ2 test. Logistic regression will be used to compare before-and-after differences, adjusting for potential confounders. The inter-rater correlation coefficient will be used to assess paired observations between a study team member and bedside ED nurses, and to describe reliability of RASS measurements.Ethics and disseminationThe Human Research Protection Office at Washington University in St. Louis School of Medicine has approved the study. The publication of peer-reviewed manuscripts and the presentation of abstracts at scientific meetings will be used to disseminate the work.RegistrationClinicalTrials.gov identifier NCT04410783; Pre-results.

Project description:ObjectivesTo characterize prehospital air medical transport sedation practices and test the hypothesis that modifiable variables related to the monitoring and delivery of analgesia and sedation are associated with prehospital deep sedation.DesignMulticenter, retrospective cohort study.SettingA nationwide, multicenter (approximately 130 bases) air medical transport provider.PatientsConsecutive, adult mechanically ventilated air medical transport patients treated in the prehospital environment (January 2015 to December 2020).InterventionsNone.Measurements and main resultsAll data involving sedation (medications, monitoring) were recorded. Deep sedation was defined as: 1) Richmond Agitation-Sedation Scale of -3 to -5; 2) Ramsay Sedation Scale of 5 or 6; or 3) Glasgow Coma Scale of less than or equal to 9. Coma was defined as being unresponsive and based on median sedation depth: 1) Richmond Agitation-Sedation Scale of -5; 2) Ramsay of 6; or 3) Glasgow Coma Scale of 3. A total of 72,148 patients were studied. Prehospital deep sedation was observed in 63,478 patients (88.0%), and coma occurred in 42,483 patients (58.9%). Deeply sedated patients received neuromuscular blockers more frequently and were less likely to have sedation depth documented with a validated sedation depth scale (i.e., Ramsay or Richmond Agitation-Sedation Scale). After adjusting for covariates, a multivariable logistic regression model demonstrated that the use of longer-acting neuromuscular blockers (i.e., rocuronium and vecuronium) was an independent predictor of deep sedation (adjusted odds ratio, 1.28; 95% CI, 1.22-1.35; p < 0.001), while use of a validated sedation scale was associated with a lower odds of deep sedation (adjusted odds ratio, 0.29; 95% CI, 0.27-0.30; p < 0.001).ConclusionsDeep sedation (and coma) is very common in mechanically ventilated air transport patients and associated with modifiable variables related to the monitoring and delivery of analgesia and sedation. Sedation practices in the prehospital arena and associated clinical outcomes are in need of further investigation.

Project description:ObjectiveKetamine has been shown to decrease sedative requirements in intensive care unit (ICU). Randomized trials are limited on patient-centered outcomes. We designed this pilot trial to evaluate the feasibility of a large randomized controlled trial (RCT) testing the effect of ketamine as an adjunct analgosedative compared with standard of care alone as a control group (CG) in critically ill patients with mechanical ventilation (MV). We also provided preliminary evidence on clinically relevant outcomes to plan a larger trial.Material and methodsPilot, active-controlled, open-label RCT was conducted at medical, surgical, and transplant ICUs at a large tertiary and quaternary care medical institution (King Faisal Specialist Hospital and Research Center, Saudi Arabia). The study included adult patients who were intubated within 24 h, expected to require MV for the next calendar day, and had institutional pain and sedation protocol initiated. Patients were randomized in a 1:1 ratio to adjunct ketamine infusion 1-2 μg/kg/min for 48 h or CG alone.ResultsOf 437 patients screened from September 2019 through November 2020, 83 (18.9%) patients were included (43 in CG and 40 in ketamine) and 352 (80.5%) were excluded. Average enrollment rate was 3-4 patients/month. Consent and protocol adherence rates were adequate (89.24% and 76%, respectively). Demographics were balanced between groups. Median MV duration was 7 (interquartile range [IQR] 3-9.25 days) in ketamine and 5 (IQR 2-8 days) in CG. Median VFDs was 19 (IQR 0-24.75 days) in ketamine and 19 (IQR 0-24 days) in the CG (p = 0.70). More patients attained goal Richmond Agitation-Sedation Scale at 24 and 48 h in ketamine (67.5% and 73.5%, respectively) compared with CG (52.4% and 66.7%, respectively). Sedatives and vasopressors cumulative use, and hemodynamic changes were similar. ICU length-of-stay was 12.5 (IQR 6-21.2 days) in ketamine, compared with 12 (IQR 5.5-23 days) in CG. No serious adverse events were observed in either group.ConclusionsKetamine as an adjunct analgosedative agent appeared to be feasible and safe with no negative impact on outcomes, including hemodynamics. This pilot RCT identified areas of improvement in study protocol before conducting a large, adequately powered, multicenter RCT which is likely justified to investigate ketamine association with patient-centered outcomes further. Trial registration ClinicalTrials.gov: NCT04075006. Registered on 30 August 2019. Current controlled trials: ISRCTN14730035. Registered on 3 February 2020.

Project description:Study objectiveAwareness with paralysis is a devastating complication for patients receiving mechanical ventilation and risks long-term psychological morbidity. Data from the emergency department (ED) demonstrate a high rate of longer-acting neuromuscular blocking agent use, delayed analgosedation, and a lack of sedation depth monitoring. These practices are discordant with recommendations for preventing awareness with paralysis. Despite this, awareness with paralysis has not been rigorously studied in the ED population. Our objective is to assess the prevalence of awareness with paralysis in ED patients receiving mechanical ventilation.MethodsThis was a single-center, prospective, observational cohort study on 383 mechanically ventilated ED patients. After extubation, we assessed patients for awareness with paralysis by using the modified Brice questionnaire. Three expert reviewers independently adjudicated awareness with paralysis. We report the prevalence of awareness with paralysis (primary outcome); the secondary outcome was perceived threat, a mediator for development of posttraumatic stress disorder.ResultsThe prevalence of awareness with paralysis was 2.6% (10/383). Exposure to rocuronium at any point in the ED was significantly different between patients who experienced awareness with paralysis (70%) versus the rest of the cohort (31.4%) (unadjusted odds ratio 5.1; 95% confidence interval 1.30 to 20.1). Patients experiencing awareness with paralysis had higher mean values on the threat perception scale, denoting a higher degree of perceived threat, compared with patients who did not experience awareness with paralysis (13.4 [SD 7.7] versus 8.5 [SD 6.2]; mean difference 4.9; 95% confidence interval 0.94 to 8.8).ConclusionAwareness with paralysis occurs in a significant minority of ED patients who receive mechanical ventilation. Potential associations of awareness with paralysis with ED care and increased perceived threat warrant further evaluation.

Project description:BackgroundProviding supplemental oxygen is fundamental in the management of mechanically ventilated patients. Increasing amounts of data show worse clinical outcomes associated with hyperoxia. However, these previous data in the critically ill have not focused on outcomes associated with brief hyperoxia exposure immediately after endotracheal intubation. Therefore, the objectives of this study were to evaluate the impact of isolated early hyperoxia exposure in the emergency department (ED) on clinical outcomes among mechanically ventilated patients with subsequent normoxia in the intensive care unit (ICU).MethodsThis was an observational cohort study conducted in the ED and ICUs of an academic center in the USA. Mechanically ventilated normoxic (partial pressure of arterial oxygen (PaO2) 60-120 mm Hg) ICU patients with mechanical ventilation initiated in the ED were studied. The cohort was categorized into three oxygen exposure groups based on PaO2 values obtained after ED intubation: hypoxia, normoxia, and hyperoxia (defined as PaO2 < 60 mmHg, PaO2 60-120 mm Hg, and PaO2 > 120 mm Hg, respectively, based on previous literature).ResultsA total of 688 patients were included. ED normoxia occurred in 350 (50.9%) patients, and 300 (43.6%) had exposure to ED hyperoxia. The ED hyperoxia group had a median (IQR) ED PaO2 of 189 mm Hg (146-249), compared to an ED PaO2 of 88 mm Hg (76-101) in the normoxia group, P < 0.001. Patients with ED hyperoxia had greater hospital mortality (29.7%), when compared to those with normoxia (19.4%) and hypoxia (13.2%). After multivariable logistic regression analysis, ED hyperoxia was an independent predictor of hospital mortality (adjusted OR 1.95 (1.34-2.85)).ConclusionsED exposure to hyperoxia is common and associated with increased mortality in mechanically ventilated patients achieving normoxia after admission. This suggests that hyperoxia in the immediate post-intubation period could be particularly injurious, and targeting normoxia from initiation of mechanical ventilation may improve outcome.

Project description:BackgroundHousing insecurity is prevalent among emergency department (ED) patients. Despite a surge of interest in screening for patients' social needs including housing insecurity, little research has examined ED social needs interventions. We worked together with government and community partners to develop and pilot test a homelessness prevention intervention targeted to ED patients with drug or unhealthy alcohol use.MethodsWe approached randomly sampled patients at an urban public hospital ED, May to August 2019. Adult patients were eligible if they were medically stable, not incarcerated, spoke English, had unhealthy alcohol or any drug use, and were not currently homeless but screened positive for risk of future homelessness using a previously developed risk screening tool. Participants received a three-part intervention: (1) brief counseling and referral to treatment for substance use delivered through a preexisting ED program; (2) referral to Homebase, an evidence-based community homelessness prevention program; and (3) up to three troubleshooting phone calls by study staff. Participants completed surveys at baseline and 6 months.ResultsOf 2183 patients screened, 51 were eligible and 40 (78.4%) participated; one later withdrew, leaving 39 participants. Participants were diverse in age, gender, race, and ethnicity. Of the 32 participants reached at 6 months, most said it was very or extremely helpful to talk to someone about their housing situation (n = 23, 71.9%) at the baseline ED visit. Thirteen (40.6%) said their housing situation had improved in the past 6 months and 16 (50.0%) said it had not changed. Twenty participants (62.5%) had made contact with a Homebase office. Participants shared ideas of how to improve the intervention.ConclusionsThis pilot intervention was feasible and well received by participants though it required a large amount of screening to identify potentially eligible patients. Our findings will inform a larger future trial and may be informative for others seeking to develop similar interventions.

Dataset Information

The Feasibility of Implementing Targeted SEDation in Mechanically Ventilated Emergency Department Patients: The ED-SED Pilot Trial.

Objectives

Design

Setting

Patients

Interventions

Measurements and main results

Conclusions

Publications

The Feasibility of Implementing Targeted SEDation in Mechanically Ventilated Emergency Department Patients: The ED-SED Pilot Trial.

Similar Datasets

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