- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07834970
Mechanical Power During Pressure Controlled Versus Volume-Controlled Ventilation in Acute Respiratory Failure (MP-PCV-VCV)
Mechanical Power During Pressure-Controlled Versus Volume Controlled Mechanical Ventilation in Patients With Acute Respiratory Failure
This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.
연구 개요
상세 설명
Mechanical ventilation is a life-saving intervention for critically ill patients with acute respiratory failure. However, mechanical ventilation can also contribute to ventilator-induced lung injury when excessive energy is delivered to the respiratory system. Mechanical power, which represents the energy transferred from the ventilator to the respiratory system per unit of time, has emerged as a potentially important parameter for assessing the intensity of mechanical ventilation.
The mode of ventilation may influence mechanical power through changes in airway pressure, tidal volume, respiratory rate, and inspiratory flow. Pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) are commonly used modes of invasive mechanical ventilation, but their effects on mechanical power in critically ill patients may differ.
Therefore, this prospective observational cohort study aims to compare mechanical power between PCV and VCV in critically ill adult patients receiving invasive mechanical ventilation and to evaluate the relationship between mechanical power and relevant clinical outcomes.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Sahar Ahmed Okily, Master degree of chest disease
- 전화번호: 01094504484 0201094504484
- 이메일: sara3hmed2012@gmail.com
연구 연락처 백업
- 이름: Hend Mohamed Sayed, Lecturer
- 전화번호: 0201098988712
- 이메일: Hendmohamed@aun.edu.eg
연구 장소
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-
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Asyut, 이집트
- Assuit university
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adult patients aged >18 years with acute respiratory failure requiring invasive mechanical ventilation and admitted to the Respiratory Intensive Care Unit at Assiut University Hospitals will be enrolled. Eligible patients receiving either pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) will be prospectively followed during their ICU and hospital stay.
설명
Inclusion Criteria:
- Adult patients aged >18 years.
- Patients with acute respiratory failure who are receiving invasive mechanical ventilation.
Exclusion Criteria:
- Patients whose condition requires shifting between VCV and PCV after enrollment.
- Patients with neurological, neuromuscular, or muscular disorders.
- Neurological disorders, e.g., stroke, multiple sclerosis, Parkinsonism, and Guillain-Barré syndrome.
- Neuromuscular junction disorders, e.g., myasthenia gravis.
- Muscular disorders, e.g., polymyositis and Duchenne muscular dystrophy.
- Chest wall abnormalities, e.g., kyphoscoliosis, scoliosis, and pectus excavatum.
- Tracheostomized patients.
- Patients with raised intra-abdominal pressure (IAP ≥12 mmHg), as estimated by transvesical manometry e.g., massive ascites, bowel obstruction, and postoperative abdominal surgery.
- Patients with documented chronic type 2 respiratory failure, characterized by an elevated partial pressure of carbon dioxide (PaCO₂ >45 mmHg), low partial pressure of oxygen (PaO₂), and chronically elevated bicarbonate (HCO₃-) reflecting renal compensation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
93 patients in Pressure controlled ventilation
93 patients in Volume controlled ventilation |
|
93 patients in PCV
93 patients in Volume controlled ventilation |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mechanical power
기간: 24 hours after intubation
|
Mechanical power will be measured and compared between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) at 24 hours after intubation. |
24 hours after intubation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
mechanical power and ICU mortality, hospital mortality, time to death.
기간: From hospital admission until 30 days after hospital admission.
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Correlation between mechanical power and ICU mortality, hospital mortality, time to death .
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From hospital admission until 30 days after hospital admission.
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Mechanical power over time
기간: At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Changes in mechanical power over time following initiation of invasive mechanical ventilation. |
At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Successful weaning from mechanical ventilation
기간: From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
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Correlation between Mechanical power and successful weaning from mechanical ventilation .Successful weaning is defined as successful extubation without the need for re-intubation or noninvasive ventilation (NIV) within the following 48 hours. |
From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Olfat Mostafa El shinawy, Professor, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
- 연구 책임자: Sara Mohamed Hashem, Lecteurer, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
간행물 및 유용한 링크
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
기타 연구 ID 번호
- AUN-CH-MP-001
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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