- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07641829
Flow-Controlled vs Volume-Controlled Ventilation in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
Investigation of the Effects of Flow-Controlled Ventilation and Volume-Controlled Ventilation on Pulmonary Dynamics and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
The goal of this clinical trial is to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on hemodynamic and respiratory parameters in obese patients undergoing elective laparoscopic bariatric surgery. The main questions it aims to answer are:
Does FCV provide better intraoperative hemodynamic and respiratory stability compared to VCV during laparoscopic bariatric surgery? Is FCV a safe and feasible ventilation strategy under high intraabdominal pressure and position changes required in bariatric surgery?
Researchers will compare FCV group to VCV group to see if FCV improves intraoperative respiratory mechanics and hemodynamic parameters.
Participants will:
Undergo elective laparoscopic bariatric surgery with BMI >40 kg/m² (ASA I-III) Receive either flow-controlled or volume-controlled ventilation with individualized PEEP and tidal volume of 6-8 ml/kg predicted body weight Have intraoperative hemodynamic and respiratory parameters monitored at regular intervals, including arterial blood gas analysis Be followed postoperatively for oxygen therapy requirement and intensive care need
연구 개요
상태
상세 설명
Laparoscopic surgery is associated with significant physiological changes due to pneumoperitoneum, which adversely affects hemodynamic and respiratory parameters, thereby complicating intraoperative anesthetic management. These challenges are particularly pronounced in obese patients, who present with reduced functional residual capacity and other physiological alterations that impact both intraoperative and postoperative outcomes.
Although bariatric surgery has conventionally been managed with volume-controlled ventilation (VCV), recent studies have highlighted the potential benefits of flow-controlled ventilation (FCV) in terms of safety and contribution to lung-protective ventilation strategies.
This study primarily aims to compare the effects of FCV and VCV on intraoperative hemodynamic and respiratory function dynamics in patients undergoing bariatric surgery. Secondarily, the study evaluates the clinical feasibility and safety of FCV under the high intraabdominal pressures and position changes required during bariatric procedures.
Study Design:
This study includes 34 patients with BMI >40 kg/m² classified as ASA I-III scheduled for elective laparoscopic bariatric surgery. Seventeen patients were prospectively managed with FCV, while data from 17 patients managed with VCV were retrospectively reviewed. All patients received standard monitoring plus intra-arterial blood pressure monitoring. Anesthesia induction and maintenance protocols were identical across both groups.
Ventilation Protocol:
In the FCV group, a tidal volume (VT) of 6-8 ml/kg predicted body weight was targeted, and positive end-expiratory pressure (PEEP) was individualized based on compliance following CO₂ insufflation. The same tidal volume strategy was applied in the VCV group with PEEP titration performed in eligible patients.
Measurements:
The following parameters were recorded after intubation, after insufflation, and at 30-minute intervals intraoperatively: mean arterial pressure (MAP), heart rate, peripheral oxygen saturation (SpO₂), plateau airway pressure (Pplat), peak airway pressure (Ppeak), driving pressure, end-tidal CO₂ (EtCO₂), minute volume, respiratory rate (RR), airway resistance (Raw), and static compliance (Cstatic) calculated as VT/(Pplat-PEEP). Arterial blood gas parameters including pH, PaCO₂, PaO₂, SaO₂, hemoglobin, and lactate were also recorded. Postoperative oxygen therapy requirement and intensive care unit admission were monitored.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Tugce Ozdogan, MD
- 전화번호: +90 5353588818
- 이메일: tugceeskin@yahoo.com.tr
연구 장소
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Ankara, 터키 (Türkiye), 06230
- 모병
- Ankara Education and Research Hospital
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연락하다:
- Tugce Ozdogan, MD
- 전화번호: +90 5353588818
- 이메일: tugceeskin@yahoo.com.tr
-
부수사관:
- Asutay Goktug, MD,PhD
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부수사관:
- Hülya Basar, MD,Phd
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부수사관:
- Mustafa Kaan Bozkurt, MD
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부수사관:
- Cetin Kaymak, MD, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age between 18 and 65 years American Society of Anesthesiologists (ASA) physical status I, II, or III Body Mass Index (BMI) ≥ 40 kg/m² Scheduled for elective laparoscopic bariatric surgery Willing to participate in the study
Exclusion Criteria:
- ASA physical status IV or V Emergency surgical procedures Pregnant patients Patients requiring vasopressor support to maintain mean arterial pressure above 65 mmHg intraoperatively Patients with advanced pulmonary disease Patients who decline to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
FCV Group
Patients undergoing elective laparoscopic bariatric surgery managed with flow-controlled ventilation (FCV) with tidal volume of 6-8 ml/kg predicted body weight and individualized PEEP based on compliance following CO₂ insufflation.
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Patients were ventilated using flow-controlled ventilation with a tidal volume of 6-8 ml/kg predicted body weight.
PEEP was individualized based on respiratory compliance following CO₂ insufflation.
다른 이름들:
|
|
VCV Group
Patients undergoing elective laparoscopic bariatric surgery managed with volume-controlled ventilation (VCV) with tidal volume of 6-8 ml/kg predicted body weight and PEEP titration performed in eligible patients.
Data collected retrospectively.
|
Patients were ventilated using volume-controlled ventilation with a tidal volume of 6-8 ml/kg predicted body weight.
PEEP titration was performed in eligible patients.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intraoperative Respiratory Mechanics
기간: From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
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Comparison of driving pressure between FCV and VCV groups at defined intraoperative time points.
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From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
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Mean Arterial Pressure
기간: From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery
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Comparison of mean arterial pressure (MAP) between FCV and VCV groups at defined intraoperative time points.
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From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pa02/Fi02 ratio
기간: From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
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Comparison of Horowitz index between FCV and VCV groups.
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From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
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Postoperative Oxygen Theraphy Need
기간: Within 24 hours after surgery
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Comparison of percentage of participants requiring postoperative oxygen therapy requirement between FCV and VCV groups.
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Within 24 hours after surgery
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Postoperative Intensive Unit Admission
기간: Within 24 hours after surgery
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Comparison of the number of patients requiring admission to the intensive care unit between the FCV and VCV groups.
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Within 24 hours after surgery
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Arterial Partial Pressure of Carbon Dioxide (PaCO2)
기간: From intubation to the end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively and at the end of the operation
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Comparison of arterial partial pressure of carbon dioxide (PaCO2) between the FCV and VCV groups to evaluate efficiency of carbon dioxide elimination at defined time points.
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From intubation to the end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively and at the end of the operation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-25-418
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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