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Annals of Intensive Care
Published in: Annals of Intensive Care 1/2015

Open Access 01-12-2015 | Research

Evaluation of a systematic approach to weaning of tracheotomized neurological patients: an early interrupted randomized controlled trial

Authors: Rosanna Vaschetto, Pamela Frigerio, Maurizio Sommariva, Arianna Boggero, Valentina Rondi, Francesca Grossi, Silvio Cavuto, Stefano Nava, Francesco Della Corte, Paolo Navalesi

Published in: Annals of Intensive Care | Issue 1/2015

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Abstract

Background

While a systematic approach to weaning reduces the rate of extubation failure in intubated brain-injured patients, no data are available on the weaning outcome of these patients after tracheotomy. We aimed to assess whether a systematic approach to disconnect tracheotomized neurological and neurosurgical patients off the ventilator (intervention) is superior to the sole physician’s judgment (control). Based on previous work in intubated patients, we hypothesized a reduction of the rate of failure within 48 h from 15 to 5 %. Secondary endpoints were duration of mechanical ventilation, ICU length of stay and mortality.

Methods

We designed a single center randomized controlled study. Since no data are available on tracheotomized patients, we based our a priori power analysis on results derived from intubated patients and calculated an overall sample size of 280 patients.

Results

After inclusion of 168 consecutive patients, the trial was interrupted because the attending physicians judged the observed rate of reconnection to be much greater than expected. The overall rate of failure was 29 %, confirming the physicians’ judgment. Twenty-one patients (24 %) in the intervention group and 27 (33 %) controls were reconnected to the ventilator within 48 h (p = 0.222). The main reasons for failure were respiratory distress (80 and 88 % in the treatment and control group, respectively), hemodynamic impairment (15 and 4 % in the treatment and control group, respectively), neurological deterioration (4 % in the control group only). The duration of mechanical ventilation was of 412 ± 202 h and 402 ± 189 h, in the control and intervention group, respectively. ICU length of stay was on average of 23 days for both groups. ICU mortality was 6 % in the control and 2 % in the intervention group without significant differences.

Conclusion

We found no difference between the two groups under evaluation, with a rate of failure much higher than expected. Consequent to the early interruption, our study results to be underpowered. Based on the results of the present study, a further trial should overall enroll 790 patients.
Trial registration: ACTRN12612000372886
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Metadata
Title
Evaluation of a systematic approach to weaning of tracheotomized neurological patients: an early interrupted randomized controlled trial
Authors
Rosanna Vaschetto
Pamela Frigerio
Maurizio Sommariva
Arianna Boggero
Valentina Rondi
Francesca Grossi
Silvio Cavuto
Stefano Nava
Francesco Della Corte
Paolo Navalesi
Publication date
01-12-2015
Publisher
Springer Paris
Published in
Annals of Intensive Care / Issue 1/2015
Electronic ISSN: 2110-5820
DOI
https://doi.org/10.1186/s13613-015-0098-0

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