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Expiratory Muscle Function in Critically Ill Ventilated Patients

Expiratory Muscle Function in Critically Ill Ventilated Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04333186
Acronym
EMFIC
Enrollment
113
Registered
2020-04-03
Start date
2017-02-15
Completion date
2020-10-16
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERData 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).

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Abdominal expiratory muscle thicknessFrom the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeksThickness of the abdominal expiratory muscles measured in millimeters

Secondary

MeasureTime frameDescription
Positive end expiratory pressureFrom the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeksPostive end expiratory pressure measure in centimetre of water
Extubation failureFrom 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 weeksReintubated after extubation
Readmission to ICUFrom 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 weeksReadmitted to ICU after the ICU discharge
Tidal volumeFrom the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeksTidal volume measured in liters
Inflammatory markersWithin 24 hours after inclusionInflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).
Applied driving pressureFrom the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeksAppplied driving pressuye defined as peak pressure minus total postive end expiratory pressure, and measured in centimetre of water
Diaphragm muscle thicknessFrom the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeksThickness of the diaphragm muscle measured in millimeters

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026