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NCT Number: NCT04333186

Expiratory Muscle Function in Critically Ill Ventilated Patients

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.

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Key information

Conditions

Mechanical Ventilation Asthenia Atrophy Critical Illness Diaphragm Disease Attributes Expiratory Muscle Muscle Atrophy or Weakness Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data from ultrasound measurements

Other

Data from ultrasound measurements and from the electronic patient record will be obtained / analyzed. One additional blood sample will be obtained within 24 hours after inclusion, during planned blood collection (from arterial line or venous puncture).

Primary outcomes

  1. 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

  1. 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

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Acronym: EMFIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 3, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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