NCT04333186: EMFIC

Expiratory Muscle Function in Critically Ill Ventilated Patients

Completed Last updated 10 November 2020

What this trial tests

trial testing Data from ultrasound measurements in Mechanical Ventilation in 113 participants. Completed in 16 October 2020.

Timeline

15 February 2017

Primary endpoint
28 November 2019

16 October 2020

Quick facts

Lead sponsor	Amsterdam UMC, location VUmc
Status	Completed
Study type	OBSERVATIONAL
Enrollment	113
Start date	15 February 2017
Primary completion	28 November 2019
Estimated completion	16 October 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Data from ultrasound measurements

Conditions studied

• Mechanical Ventilation — all drugs for Mechanical Ventilation →
• Expiratory Muscle — all drugs for Expiratory Muscle →
• Critical Illness — all drugs for Critical Illness →
• Muscle Atrophy or Weakness — all drugs for Muscle Atrophy or Weakness →

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

18 and older, any sex, with Mechanical Ventilation or Expiratory Muscle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied.

The main expiratory muscles are the abdominal wall muscles, including the external oblique (EO), internal oblique (IO) and transversus abdominis muscles (TRA). These muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. The abdominal wall muscles are also critical for protective reflexes, such as coughing. Reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. This will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (VAP). Studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. Further, high mortality was found in patients with low peak expiratory flow.

Considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (MV) for critically ill patients are still unknown.

Ultrasound is increasingly used in the ICU for the visualization of respiratory muscles. In a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). Accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during MV in adult critically ill patients, using ultrasound data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.