- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07702422
The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation
The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation: A Prospective Cohort Study.
Approximately 20% of patients in the intensive care unit (ICU) requiring mechanical ventilation (MV) experience difficulty and prolonged weaning. Early spontaneous breathing trials (SBT) and timely extubation are essential to avoid complications such as diaphragmatic dysfunction, ventilator-associated pneumonia, and airway trauma.
Mechanical ventilation is a vital supportive therapy in critical care. However, both delayed weaning and premature discontinuation are associated with poor outcomes and prolonged ICU stay. Prolonged MV may lead to complications including respiratory muscle dysfunction, ventilator-associated lung injury, and increased healthcare costs, emphasizing the importance of optimal timing of weaning.
Ultrasonography (US) has emerged as a rapid, non-invasive bedside tool for real-time assessment of respiratory muscle function. It allows evaluation of muscle thickness and contractility, aiding in the detection of diaphragmatic dysfunction.
In cases of diaphragmatic impairment, accessory respiratory muscles, particularly the parasternal intercostal muscles, play a compensatory role. Measurement of parasternal intercostal muscle thickness fraction (PICTF%) has been proposed as a predictor of weaning failure.
Additionally, composite indices such as the rapid shallow breathing index (RSBI) and compliance, rate, oxygenation, and pressure (CROP) index are widely used to assess weaning readiness. A recently proposed composite index combining PICTF (>9%) and diaphragmatic excursion (<15 mm) demonstrated high predictive value for failure of non-invasive ventilation.
Therefore, the present study aims to evaluate the effectiveness of this novel composite index in predicting weaning failure in mechanically ventilated patients.
연구 개요
상태
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
- All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
- Neuromuscular diseases.
- Severe head injury.
- Pregnant and lactating women.
설명
Inclusion Criteria:
- Age ≥ 18 years old.
- Both sexes.
- Patients who have been mechanically ventilated for more than 48 h.
Exclusion Criteria:
- All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
- Neuromuscular diseases.
- Severe head injury.
- Pregnant and lactating women.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Ability of a combined PICTF% and diaphragmatic excursion to predict weaning failure .
기간: 5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail
|
Parasternal intercostal muscle thickening fraction (%) measured by ultrasound at 5 minutes after the start of the spontaneous breathing trial to evaluate its ability to predict weaning failure and diaphragmatic excursion
|
5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
• Difference between PICTF % at 5 and 60 min OF SBT. • RSBI at 5and 60 min of SBT. • Correlation between PICTF% and RSBI Diaphragmatic excursion
기간: at 5 mintues of spontanous breathing trail and at 60 minutes
|
at 5 mintues of spontanous breathing trail and at 60 minutes
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- md-461-2024
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .