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Clinical Trials/NCT04333186
NCT04333186
Completed
Not Applicable

Expiratory Muscle Function in Critically Ill Ventilated Patients

Amsterdam UMC, location VUmc1 site in 1 country113 target enrollmentFebruary 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Amsterdam UMC, location VUmc
Enrollment
113
Locations
1
Primary Endpoint
Abdominal expiratory muscle thickness
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2017
End Date
October 16, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Prof.dr. L.M.A. Heunks

Principal Investigator

Amsterdam UMC, location VUmc

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Extubation failure(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)
  • Positive end expiratory pressure(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)
  • Diaphragm muscle thickness(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(Within 24 hours after inclusion)
  • Applied driving pressure(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(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)
  • Readmission to ICU(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)

Study Sites (1)

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