Expiratory Muscle Function in Critically Ill Ventilated Patients

NCT04333186 | Completed

• 1 other identifier: EMFIC
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Expiratory Muscle; Critical Illness; Muscle Atrophy or Weakness; Diaphragm

Outcome Measures

Primary Outcomes (1)

• Abdominal expiratory muscle thickness

  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 Outcomes (7)

• 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

• 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

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient on mechanical ventilation in the intensive care

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

One blood sample

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy; Asthenia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Leo M Heunks

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 3, 2020
• Study Start: February 15, 2017
• Primary Completion: November 28, 2019
• Study Completion: October 16, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

NL (1)