Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre

BMJ Open, 2023 · DOI: 10.1136/bmjopen-2022-071273 · Published: January 1, 2023

Simple Explanation

Patients with neurological conditions often have difficulty coughing, which can lead to serious complications like pneumonia. This study investigates whether using a mechanical device called MI-E can help these patients wean off mechanical ventilation faster. The study will randomly assign patients to receive either standard care or standard care plus MI-E. Researchers will then compare how long it takes for patients in each group to successfully wean from mechanical ventilation. The results of this study will help determine if MI-E is an effective treatment for improving weaning outcomes in neurological patients with cough deficiency.

Study Duration

Until 16 April 2025

Participants

100 adult patients with cough deficiency or retention of secretion

Evidence Level

Level 1: Single-centre randomised controlled study

Key Findings

1
The primary endpoint of this trial is the duration of mechanical ventilation from randomisation until successful weaning.
2
Secondary endpoint is the proportion of patients with successful weaning.
3
Further outcomes will include the incidence of hospital-acquired pneumonia, mortality, decannulation rate, length of stay on the ICU and the total score of the Glasgow Coma Scale.

Research Summary

This study is a single-center randomized controlled trial designed to assess the efficacy of mechanical insufflation-exsufflation (MI-E) in reducing the duration of mechanical ventilation for neurological patients with cough deficiency. The trial plans to recruit 100 adult patients admitted to a neurological intensive care unit (ICU) who suffer from cough deficiency or retention of secretion. Patients will be randomized to either receive MI-E in addition to standard care or standard care alone, and will be observed until discharge, death, or the end of the study period.

Practical Implications

Clinical Practice

The study aims to provide evidence for the use of MI-E in neurological patients during weaning from mechanical ventilation, potentially leading to improved clinical guidelines.

Future Research

The findings will inform the design of larger, multi-center trials to further validate the effectiveness of MI-E.

Resource Allocation

If MI-E proves effective, it could justify increased investment in this technology and training for healthcare professionals.

Study Limitations

1
Treatment arms are not blinded.
2
Due to uncertainty regarding the effect size, no formal sample size estimation was conducted for this pilot study.
3
Study is a single-center trial, which may limit the generalizability of the findings.

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