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

Cristiane Bastos Netto; Maycon Moura Reboredo; Rodrigo Souza Vieira; Lídia Maria Carneiro da Fonseca; Elivaldo Cyrillo Júnior; André Luís Dias de Souza; Erich Vidal Carvalho; Bruno Valle Pinheiro

doi:10.1016/j.medine.2024.502125

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

Med Intensiva (Engl Ed). 2025 Jan 6:502125. doi: 10.1016/j.medine.2024.502125. Online ahead of print.

Authors

Cristiane Bastos Netto¹, Maycon Moura Reboredo², Rodrigo Souza Vieira¹, Lídia Maria Carneiro da Fonseca², Elivaldo Cyrillo Júnior¹, André Luís Dias de Souza¹, Erich Vidal Carvalho², Bruno Valle Pinheiro³

Affiliations

¹ Pulmonary and Critical Care Division, University Hospital of Federal University of Juiz de Fora, Brazil.
² Pulmonary and Critical Care Division, University Hospital of Federal University of Juiz de Fora, Brazil; School of Medicine, Federal University of Juiz de Fora, Minas Gerais, Brazil.
³ Pulmonary and Critical Care Division, University Hospital of Federal University of Juiz de Fora, Brazil; School of Medicine, Federal University of Juiz de Fora, Minas Gerais, Brazil. Electronic address: bvallepinheiro@gmail.com.

PMID: 39765380
DOI: 10.1016/j.medine.2024.502125

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.

Keywords: Destete; Dispositivo médico; Mechanical ventilation; Medical device; Secreción; Secretion; Tracheostomy; Traqueostomía; Ventilación mecánica; Weaning.