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The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study.

ABSTRACT: BACKGROUND:Studies evaluating nicotine replacement therapy (NRT) to prevent nicotine withdrawal symptoms in ICU patients have yielded conflicting results. We performed a randomised controlled double-blind pilot study to assess the safety and efficacy of NRT in critically ill patients. Mechanically ventilated patients admitted to two medical-surgical intensive care units and smoking more than 10 cigarettes per day before ICU admission were enrolled in this study. Participants were randomised to transdermal NRT (14 or 21 mg per day) or placebo until ICU discharge or day 30. Smoking status was confirmed by the biomarkers serum cotinine and urinary NNAL. The primary endpoint was 30-day mortality. Among secondary endpoints and post hoc endpoints, 90-day mortality, safety, time spent without delirium, sedation and coma, and patient destination at day 30 were addressed. RESULTS:We enrolled 47 patients. No differences were found between NRT and control group patients concerning 30-day mortality (9.5 vs. 7.7%, p?=?0.84) and 90-day mortality (14.3 vs. 19.2%, p?=?0.67). The number of serious adverse events was comparable between groups (NRT: 4, control: 11, p?=?0.13). At day 20, average time alive without delirium, sedation and coma was 16.6 days among NRT patients versus 12.6 days among control patients (p?=?0.03). At day 30, more NRT group patients were discharged from the ICU or hospital compared with controls (p?=?0.03). CONCLUSIONS:NRT did not affect mortality or the number of (serious) adverse events compared with placebo. Time alive without delirium, sedation and coma at day 20 in NRT patients was longer than in control patients. An adequately powered randomised controlled trial to further study safety and efficacy of NRT in ICU patients seems feasible and is warranted. Trial registration ClinicalTrials.gov, number NCT01362959, registered 1 June 2011.

SUBMITTER: de Jong B

PROVIDER: S-EPMC5991106 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study.

de Jong Ben B Schuppers Anne Sophie AS Kruisdijk-Gerritsen Arriette A Arbouw Maurits Erwin Leo MEL van den Oever Hubertus Laurentius Antonius HLA van Zanten Arthur R H ARH

Annals of intensive care 20180607 1

<h4>Background</h4>Studies evaluating nicotine replacement therapy (NRT) to prevent nicotine withdrawal symptoms in ICU patients have yielded conflicting results. We performed a randomised controlled double-blind pilot study to assess the safety and efficacy of NRT in critically ill patients. Mechanically ventilated patients admitted to two medical-surgical intensive care units and smoking more than 10 cigarettes per day before ICU admission were enrolled in this study. Participants were randomi ...[more]

PMID: 29881956

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Project description:Background Mini-sternotomy for isolated aortic valve replacement aims to reduce operative trauma hastening recovery and improving the cosmetic outcome of cardiac surgery. The short-term clinical benefits from the mini-sternotomy are presumed to arise because the incision is less extensive and the lower half of the chest cage remains intact. The basic conduct of virtually all other aspects of the aortic valve replacement procedure remains the same. Therefore, similar long-term outcomes are to be expected. Objectives To conduct a meta-analysis of the only available randomised controlled trials (RCT) in the published English literature. Data sources Electronic search for relevant publications in MEDLINE, EMBASE and CENTRAL databases were performed. Four studies met the criteria. Study eligibility criteria RCT comparing minimally invasive (inverted C or L (J)-shaped) hemi-sternotomy versus conventional sternotomy for adults undergoing isolated aortic valve replacement using standard cardiopulmonary bypass technique. Methods Outcome measures were the length of positive pressure ventilation, blood loss, intensive care unit (ICU) and hospital stay. Results The length of ICU stay was significantly shorter by 0.57 days in favour of the mini-sternotomy group (CI -0.95 to -0.2; p=0.003). There was no advantage in terms of duration of ventilation (CI -3.48 to 0.36; p=0.11). However, there was some evidence to suggest a reduction in blood loss and the length of stay in hospital in the mini-sternotomy group. This did not prove to be statistically significant (154.17 ml reduction (CI -324.51 to 16.17; p=0.08) and 2.03 days less (CI -4.12 to 0.05; p=0.06), respectively). Limitations This study includes a relatively small number of subjects (n=220) and outcome variables. The risk of bias was not assessed during this meta-analysis. Conclusion Mini-sternotomy for isolated aortic valve replacement significantly reduces the length of stay in the cardiac ICU. Other short-term benefits may include a reduction in blood loss or the length of hospital stay.

Project description:ObjectiveTo establish the role of high-fidelity simulation training to test the efficacy and safety of the electronic health record (EHR)-user interface within the intensive care unit (ICU) environment.DesignProspective pilot study.SettingMedical ICU in an academic medical centre.ParticipantsPostgraduate medical trainees.InterventionsA 5-day-simulated ICU patient was developed in the EHR including labs, hourly vitals, medication administration, ventilator settings, nursing and notes. Fourteen medical issues requiring recognition and subsequent changes in management were included. Issues were chosen based on their frequency of occurrence within the ICU and their ability to test different aspects of the EHR-user interface. ICU residents, blinded to the presence of medical errors within the case, were provided a sign-out and given 10 min to review the case in the EHR. They then presented the case with their management suggestions to an attending physician. Participants were graded on the number of issues identified. All participants were provided with immediate feedback upon completion of the simulation.Primary and secondary outcomesTo determine the frequency of error recognition in an EHR simulation. To determine factors associated with improved performance in the simulation.Results38 participants including 9 interns, 10 residents and 19 fellows were tested. The average error recognition rate was 41% (range 6-73%), which increased slightly with the level of training (35%, 41% and 50% for interns, residents, and fellows, respectively). Over-sedation was the least-recognised error (16%); poor glycemic control was most often recognised (68%). Only 32% of the participants recognised inappropriate antibiotic dosing. Performance correlated with the total number of screens used (p=0.03).ConclusionsDespite development of comprehensive EHRs, there remain significant gaps in identifying dangerous medical management issues. This gap remains despite high levels of medical training, suggesting that EHR-specific training may be beneficial. Simulation provides a novel tool in order to both identify these gaps as well as foster EHR-specific training.

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The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study.

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The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study.

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