Expiratory Muscle Function in Critically Ill Ventilated Patients

Critical Illness Clinical Trial

— EMFIC  

Official title:

Expiratory Muscle Function in Critically Ill Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333186
• Other study ID #: EMFIC
• Status: Completed
• Start date: February 15, 2017
• Est. completion date: October 16, 2020

Study information

• Verified date: November 2020
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 16, 2020
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Critical Illness
• Diaphragm
• Expiratory Muscle
• Mechanical Ventilation
• Muscle Atrophy or Weakness
• Muscular Atrophy

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diaphragm muscle thickness	Thickness of the diaphragm muscle 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	Inflammatory markers	Inflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).	Within 24 hours after inclusion
Secondary	Applied driving pressure	Appplied driving pressuye defined as peak pressure minus total postive end expiratory pressure, and measured in centimetre of water	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	Tidal volume	Tidal volume measured in liters	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	Positive end expiratory pressure	Postive end expiratory pressure measure in centimetre of water	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	Extubation failure	Reintubated after extubation	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
Secondary	Readmission to ICU	Readmitted to ICU after the ICU discharge	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