복강경 수술 중 PRVC 환기 시 최고 기도 압력과 호흡 역학
복강경 복부 수술을 받는 환자에서 압력 조절 용량 조절 환기 중 최고 기도압 및 호흡 역학: 전향적 관찰 연구
This study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Pneumoperitoneum and patient positioning during laparoscopic procedures can significantly affect respiratory mechanics, including airway pressures and lung compliance.
The study will assess changes in peak airway pressure, dynamic compliance, and other ventilatory parameters during different intraoperative phases. The findings are expected to provide insights into optimizing ventilatory strategies to improve patient safety and minimize ventilator-associated complications during laparoscopic surgery.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Laparoscopic abdominal surgery requires the creation of pneumoperitoneum, which increases intra-abdominal pressure and affects respiratory system mechanics. These changes can lead to increased peak airway pressure and reduced lung compliance, potentially increasing the risk of ventilator-induced lung injury.
Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume with the lowest possible airway pressure by adjusting inspiratory pressure dynamically. However, its performance during laparoscopic procedures and its effect on respiratory mechanics require further evaluation.
This prospective observational study will be conducted on adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Standardized anesthesia and ventilation protocols will be applied. Respiratory parameters including peak airway pressure, plateau pressure, tidal volume, respiratory rate, and dynamic compliance will be recorded at three predefined stages, each after a minimum 5-minute stabilization interval: after induction and intubation (supine, before pneumoperitoneum), after establishment of pneumoperitoneum, and after final surgical positioning.
The primary outcome will be the change in peak airway pressure across the three stages. Secondary outcomes include dynamic compliance and other ventilatory and hemodynamic parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
연구 장소
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-
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Riyadh, 사우디 아라비아
- SpecializedMedicalCenter
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
설명
Inclusion Criteria:
- Adult patients aged 18-65 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- ASA physical status I-II
- Patients requiring mechanical ventilation using PRVC mode
- Provided informed consent
Exclusion Criteria:
- Patients with significant cardiopulmonary disease
- Chronic obstructive pulmonary disease or restrictive lung disease
- Morbid obesity (BMI > 35 kg/m²)
- Pregnancy
- Emergency surgeries
- Patients with anticipated difficult airway
- Refusal to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Single Cohort
Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia with pressure-regulated volume control (PRVC) ventilation. Respiratory parameters are recorded at predefined intraoperative time points. |
Mechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Airway Pressure
기간: At 0, 5, and 10 minutes intraoperatively
|
Peak airway pressure (PIP) measured intraoperatively using the anesthesia workstation under standardized pressure-regulated volume control ventilation settings. |
At 0, 5, and 10 minutes intraoperatively
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Dynamic Compliance
기간: At 0, 5, and 10 minutes intraoperatively
|
Dynamic lung compliance (Cdyn) measured intraoperatively using standard anesthesia monitoring at predefined time points. |
At 0, 5, and 10 minutes intraoperatively
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|
Plateau Pressure
기간: At 0, 5, and 10 minutes intraoperatively
|
Plateau pressure (Pplat) measured during controlled ventilation using the anesthesia workstation. |
At 0, 5, and 10 minutes intraoperatively
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End-tidal Carbon Dioxide
기간: At 0, 5, and 10 minutes intraoperatively
|
End-tidal carbon dioxide (EtCO2) measured continuously during mechanical ventilation. |
At 0, 5, and 10 minutes intraoperatively
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|
Mean Airway Pressure
기간: At 0, 5, and 10 minutes intraoperatively
|
Mean airway pressure measured intraoperatively using the anesthesia workstation. |
At 0, 5, and 10 minutes intraoperatively
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|
Oxygen Saturation
기간: At 0, 5, and 10 minutes intraoperatively
|
Peripheral oxygen saturation (SpO2) monitored continuously during surgery. |
At 0, 5, and 10 minutes intraoperatively
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|
Heart Rate (beats/min)
기간: At 0, 5, and 10 minutes intraoperatively
|
Heart rate measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
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|
Mean Arterial Pressure (mmHg)
기간: At 0, 5, and 10 minutes intraoperatively
|
Mean arterial pressure measured intraoperatively using standard monitoring |
At 0, 5, and 10 minutes intraoperatively
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Minute Ventilation
기간: At 0, 5, and 10 minutes intraoperatively
|
Minute ventilation recorded from the anesthesia workstation during controlled ventilation. |
At 0, 5, and 10 minutes intraoperatively
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IRB-002-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
No, individual participant data (IPD) will not be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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