The impact of mechanical insufflation-exsufflation on the weaning success rate of tracheostomized patients on prolonged mechanical ventilation: a pilot and feasibility study of a randomized controlled trial

Abstract

Objective

To evaluate the feasibility of adding mechanical insufflation-exsufflation (MI-E) to a weaning protocol for tracheostomized patients undergoing prolonged mechanical ventilation (MV).

Design

Single-center, open-label, randomized, controlled pilot and feasibility study.

Setting

Intensive care unit in Brazil.

Patients

Tracheostomized adults who were invasively ventilated for more than 14 days and who were weaned from MV.

Interventions

Patients were randomized into two groups: intervention group (IG) or a control group (CG). During weaning with a tracheostomy collar, the IG received two daily sessions of MI-E, each with 5 cycles (insufflation and exsufflation pressures of 45 cm H₂O). The CG received conventional chest physiotherapy.

Main variables of interest

The primary outcomes were the feasibility of adding MI-E to the weaning protocol and the rate of successful weaning.

Results

A total of 47 patients were randomized, with 25 in the IG and 22 in the CG. All patients randomized to the MI-E group received the proposed protocol, completing all the scheduled MI-E sessions. Adverse events occurred in 14% of the MI-E sessions, but they did not lead to treatment interruption. Weaning success was observed in 76% of IG patients and 73% of CG patients (relative risk, 1.05; 95% CI, 0.75–1.46). No significant differences were observed between the IG and CG regarding ICU mortality (16% and 18%, respectively, p = 0.99) or hospital mortality (40% and 41%, respectively, p = 0.99).

Conclusions

The addition of MI-E to the standard weaning protocol is feasible, but not result in a greater rate of successful weaning in tracheostomized patients.

Clinical trial registration number

U1111-1302-9035.