Expiratory Muscle Function in Critically Ill Ventilated Patients

NCT ID: NCT04333186

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2020-10-16

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Data from ultrasound measurements

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Prof.dr. L.M.A. Heunks

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leo M Heunks

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

VU University Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EMFIC

Identifier Type: -

Identifier Source: org_study_id