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Original article
Available online 7 January 2025
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
El impacto de la insuflación-exsuflación mecánica en la tasa de éxito del destete de pacientes con traqueostomía en ventilación mecánica prolongada: un ensayo controlado aleatorio piloto y de factibilidad
Cristiane Bastos Nettoa, Maycon Moura Reboredoa,b, Rodrigo Souza Vieiraa, Lídia Maria Carneiro da Fonsecaa,b, Elivaldo Cyrillo Júniora, André Luís Dias de Souzaa, Erich Vidal Carvalhoa,b, Bruno Valle Pinheiroa,b,
Corresponding author
bvallepinheiro@gmail.com

Corresponding author.
a Pulmonary and Critical Care Division, University Hospital of Federal University of Juiz de Fora, Brazil
b School of Medicine, Federal University of Juiz de Fora, Minas Gerais, Brazil
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Figures (2)
Tables (4)
Table 1. Baseline patient characteristics.
Table 2. Clinical and ventilatory characteristics of patients at randomization.
Table 3. Primary and secondary outcomes according to study group.
Table 4. Multivariate logistic regression to evaluate the associations between mechanical insufflation-exsufflation and weaning success and hospital mortality.
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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:
Mechanical ventilation
Tracheostomy
Medical device
Secretion
Weaning
Resumen
Objetivo

Evaluar la factibilidad de añadir insuflación-exsuflación mecánica (MI-E) a un protocolo de destete para pacientes con traqueostomía sometidos a ventilación mecánica (VM) prolongada.

Diseño

Estudio piloto y de factibilidad, abierto, aleatorizado y controlado en un solo centro.

Ámbito

Unidad de cuidados intensivos en Brasil.

Pacientes

Adultos con traqueostomía que fueron ventilados de forma invasiva durante más de 14 días y que se encontraban en proceso de destete de la VM.

Intervenciones

Los pacientes fueron aleatorizados en dos grupos: grupo de intervención (IG) y grupo de control (CG). Durante el destete con un collar de traqueostomía, el IG recibió dos sesiones diarias de MI-E, cada una con 5 ciclos (presiones de insuflación y exsuflación de 45 cm H2O). El CG recibió fisioterapia torácica convencional.

Variables principales de interés

Los resultados primarios fueran la factibilidad de añadir insuflación-exsuflación mecánica (MI-E) a un protocolo de destete y la tasa de destete exitoso.

Resultados

Un total de 47 pacientes fueron aleatorizados, con 25 en el IG y 22 en el CG. Todos los pacientes del grupo MI-E recibieron el tratamiento propuesto y completaron todas sesiones de MI-E programadas. Los eventos adversos ocurrieron en el 14% de las sesiones de MI-E, pero no llevaron a la interrupción del tratamiento. El éxito del destete se observó en el 76% de los pacientes del IG y en el 73% de los pacientes del CG (riesgo relativo, 1.05; IC del 95%, 0.75 a 1.46). No se observaron diferencias significativas entre el IG y el CG respecto a la mortalidad en la UCI (16% y 18%, respectivamente, p = 0.99) ni a la mortalidad hospitalaria (40% y 41%, respectivamente, p = 0.99).

Conclusión

La adición de MI-E al protocolo estándar de destete és factible, pero no resultó en una mayor tasa de destete exitoso en pacientes con traqueostomía.

Palabras clave:
Ventilación mecánica
Traqueostomía
Dispositivo médico
Secreción
Destete

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