Expiratory Muscle Function in Critically Ill Ventilated Patients (EMFIC)

November 9, 2020 updated by: Prof.dr. L.M.A. Heunks, Amsterdam UMC, location VUmc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HV
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient on mechanical ventilation in the intensive care

Description

Inclusion Criteria:

  • Age > 18 years
  • Invasive mechanical ventilation < 48 hours
  • Expected duration of mechanical ventilation > 72 hours

Exclusion Criteria:

  • Past medical history of neuromuscular disorders
  • Mechanical ventilation > 48 hours within the current hospital admission
  • Pregnant women
  • Open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal expiratory muscle thickness
Time Frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Thickness of the abdominal expiratory muscles measured in millimeters
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm muscle thickness
Time Frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Thickness of the diaphragm muscle measured in millimeters
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Inflammatory markers
Time Frame: Within 24 hours after inclusion
Inflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).
Within 24 hours after inclusion
Applied driving pressure
Time Frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Appplied driving pressuye defined as peak pressure minus total postive end expiratory pressure, and measured in centimetre of water
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Tidal volume
Time Frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Tidal volume measured in liters
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Positive end expiratory pressure
Time Frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Postive end expiratory pressure measure in centimetre of water
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Extubation failure
Time Frame: From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks
Reintubated after extubation
From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks
Readmission to ICU
Time Frame: From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks
Readmitted to ICU after the ICU discharge
From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Leo M Heunks, Amsterdam Umc, Location Vumc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

November 28, 2019

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMFIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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