- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06321848
심장, 폐, 횡격막 초음파를 이용한 이유식 인공호흡기
수술 중환자의 인공호흡기 이탈 결과에 대한 심장, 폐 및 횡경막 초음파의 예측 가치
Postextubation distress is detrimental to the prognosis of critically ill patients with successful spontaneous breathing trial. Failure to wean is known to be connected with heart, lung, and diaphragm problems. The aim of this study was to investigate how a composite model comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning outcome.
Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected along with clinical data about the patients. Either the successful weaning group or the failed weaning group is going to comprised the patients. Multivariate logistic regression analysis is going to be used to identify the variables that may be associated with the likelihood of weaning failure. A multiindicator combination model is going to be developed to increase the predictive accuracy after the possible indicators' accuracy in foretelling the weaning outcome was assessed.
연구 개요
상세 설명
- Research participants: From March 2024 to March 2026 in the Department of Anesthesia, critical care and pain medicine, Hanoi Medical University Hospital, patients ages over 18 years who will have mechanically ventilated for over 48 h will be recruited. Patients will be excluded if they had a diagnosis of progressive neuromuscular diseases, a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma), patients with thoracic surgery and mitral valve surgery. All patients and their families signed informed consents.
- Clinical data collection: Clinical data including gender, age, body mass index, primary disease, length of stay in ICU, duration of mechanical ventilation, acute physiology and chronic health evaluation II, Charlson Comorbidity Index, history of surgery/internal diseases will be collected.
- Spontaneous breathing trial (SBT): Patients will be undergone a 60-min SBT when they meet all the readiness weaning criteria with PS 7cmH2O, PEEP 5cmH2O, FiO2 40%. The vital signs, rapid shallow breathing index (RSBI), NIF, P0.1, tidal volume, respiratory rate, arterial blood gases will be recorded at the beginning and at the end of SBT.
GE Logiq P7 (GE Healthcare, USA) and Philips Affiniti 70G (Philips Ultrasound, USA) ultrasound diagnostic instruments will be used in this study. The heart, lung and diagphragm ultrasonic findings will be recorded by the sonographer well trained in point-of-care ultrasound at the begining and at the end of the SBT.
Tracheal extubation is carried out if the patient does not exhibit symptoms of intolerance, indicating that the SBT treatment was successful. In case intolerance symptoms manifest, return to the initially chosen breathing mode (SIMV, A/C) and record the SBT failure.
- Extubation: After successful SBT: proceed with extubation. The patient is given an oxygen mask at 5L/minute. If the patient does not show intolerance symptoms within 48 hours, the extubation is considered successful. If the patient develops one of the intolerance symptoms during this time period, the extubation failure will be recorded and the patients will be reintubated. Record the values of vital signs and arterial blood gas variables every 24, 48 hours after extubation.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Hanoi, 베트남, 100000
- Hanoi Medical University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
All patients with a duration of mechanical ventilation through an endotracheal tube of more than 48 hours and meeting the criteria of readiness to wean off mechanical ventilation will be included in the study.
설명
Inclusion Criteria:
- Age >= 18
- The duration of postoperative mechanical ventilation >= 48 hours
Exclusion Criteria:
- Patient had a diagnosis of progressive neuromuscular diseases
- Patient had a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma)
- Patients had thoracic surgery or mitral valve surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: ECOLOGIC_OR_COMMUNITY
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
|
The ventilator weaning patients
Patients who have been on mechanical breathing for longer than 48 hours using an endotracheal tube and who fit the requirements to be weaned off of it |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The ventilator weaning outcome
기간: after 48 hours of extubation
|
The outcome of weaning ventilation process (successful or failure) |
after 48 hours of extubation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The hospital length of stay
기간: Approximately 5-15 days postextubation
|
The time between hospital admission and discharge |
Approximately 5-15 days postextubation
|
|
The ICU length of stay
기간: Approximately 2-15 days postextubation
|
The time between ICU admission and discharge |
Approximately 2-15 days postextubation
|
|
The duration of mechanical ventilation
기간: Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months
|
The time from the start of mechanical ventilation to extubation |
Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Tu Nguyen, Professor, Hanoi Medical University
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 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The investigators agree that all results and conclusion of this research will be used fully for other researchers
IPD 공유 기간
from March 2026 to the unidentified time
IPD 공유 액세스 기준
anesthesiologists all over the world
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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