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Open Access 01-12-2018 | Research

Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial

Authors: Nazzareno Fagoni, Simone Piva, Elena Peli, Fabio Turla, Elisabetta Pecci, Livio Gualdoni, Bertilla Fiorese, Frank Rasulo, Nicola Latronico

Published in: Annals of Intensive Care | Issue 1/2018

Abstract

Background

Weaning protocols expedite extubation in mechanically ventilated patients, yet the literature investigating the application in tracheostomized patients remains scarce. The primary objective of this parallel randomized controlled pilot trial (RCT) was to assess the feasibility and safety of a nurse-led weaning protocol (protocol) compared to weaning based on physician’s clinical judgment (control) in tracheostomized critically ill patients.

Results

We enrolled 65 patients, 27 were in the protocol group and 38 in the control group. Of 27 patients in the protocol group, 1 (3.7%) died in the ICU, 24 (88.9%) were successfully weaned from tracheostomy, and 2 (7.4%) were transferred still on the ventilator. Of 38 patients in the control group, 2 (5.3%) died in the ICU, 22 (57.9%) were successfully weaned from tracheostomy, and 14 were transferred still on the ventilator (36.8%). Risk of being discharged from the ICU on the ventilator was higher in the control group (relative risk: 1.5, IC 95% 1.14–2.01). Concerning safety and feasibility, no patients were excluded after randomization. There was no crossover between the two study arms nor missing data, and no severe adverse event related to the study protocol application was recorded by the staff. Weaning time and rate of successful weaning were not different in the protocol group compared to the control group (long-rank test, p = 0.31 for MV duration, p = 0.45 for weaning time). Based on our results and assuming a 30% reduction of the weaning time for the protocol group, 280 patients would be needed for a RCT to establish efficacy.

Conclusions

In this pilot RCT we demonstrated that a nurse-led weaning protocol from tracheostomy was feasible and safe. A larger RCT is justified to assess efficacy.

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Title: Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial
Authors: Nazzareno Fagoni
Simone Piva
Elena Peli
Fabio Turla
Elisabetta Pecci
Livio Gualdoni
Bertilla Fiorese
Frank Rasulo
Nicola Latronico
Publication date: 01-12-2018
Publisher: Springer International Publishing
Published in: Annals of Intensive Care / Issue 1/2018
Electronic ISSN: 2110-5820
DOI: https://doi.org/10.1186/s13613-018-0354-1

At a glance: The STEP trials

Springer Medicine

Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial

Abstract

Background

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Results

Conclusions

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