Expiratory Muscle Function in Critically Ill Ventilated Patients (EMFIC)
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.
연구 개요
상태
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, 네덜란드, 1081HV
- VU University Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Abdominal expiratory muscle thickness
기간: 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
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diaphragm muscle thickness
기간: 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
|
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
기간: Within 24 hours after inclusion
|
Inflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).
|
Within 24 hours after inclusion
|
|
Applied driving pressure
기간: 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
|
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
기간: 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
|
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
기간: 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
|
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
|
|
Extubation failure
기간: 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
|
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
|
|
Readmission to ICU
기간: 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
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Leo M Heunks, Amsterdam UMC, location VUmc
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .