BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery (SIMPLE-PEEP)
Effect of Body Mass Index-Adjusted Positive End-Expiratory Pressure on Respiratory Mechanics During One-Lung Ventilation in Thoracic Surgery
One-lung ventilation (OLV) is required during many thoracic surgical procedures and is associated with reduced functional residual capacity, atelectasis, ventilation-perfusion mismatch, hypoxemia, and potentially ventilator-induced lung injury. Lung-protective ventilation strategies include low tidal volumes, limitation of airway pressures, and positive end-expiratory pressure (PEEP), but the optimal PEEP level during OLV remains uncertain. Fixed PEEP is simple and reproducible but does not account for individual patient characteristics. Body mass index (BMI) is readily available before anesthesia and is associated with respiratory mechanics, making it a pragmatic candidate for simple PEEP individualization.
SIMPLE-PEEP is a prospective, multicenter, pragmatic, open-label, randomized clinical trial including 150 adults undergoing elective pulmonary resection under general anesthesia requiring OLV. Participants will be randomized to either fixed PEEP of 4 cmH2O or BMI-adjusted PEEP calculated as BMI/3 cmH2O. Other key components of lung-protective ventilation will be standardized between groups.
The primary outcome is driving pressure during the first 20 minutes of OLV, assessed at 5, 10, and 20 minutes after OLV initiation. Secondary outcomes include respiratory system compliance and other respiratory mechanics, estimated mechanical power, oxygenation, intraoperative hypoxemia and rescue maneuvers, hemodynamic safety, vasopressor requirements, and exploratory postoperative respiratory outcomes. No investigational medicinal product, additional invasive procedure, or study-specific advanced monitoring is required.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jesús M Nieves Alonso, MD
- 전화번호: +34915202540
- 이메일: jesusmna@gmail.com
연구 장소
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Catalonia
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Barcelona, Catalonia, 스페인, 08036
- 아직 모집하지 않음
- Hospital Clinic Barcelona
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연락하다:
- Manuel L López
- 이메일: LOPEZ10@clinic.cat
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Barcelona, Catalonia, 스페인, 08041
- 아직 모집하지 않음
- Hospital de la Santa Creu i Sant Pau
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연락하다:
- Ana P Parera
- 이메일: AParera@santpau.cat
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Madrid
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Madrid, Madrid, 스페인, 28006
- 모병
- Hospital Universitario de La Princesa
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연락하다:
- Jesús M Nieves Alonso, MD
- 전화번호: +34915202540
- 이메일: jesusmna@gmail.com
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Madrid, Madrid, 스페인, 28007
- 아직 모집하지 않음
- Hospital General Universitario Geogorio Marañón
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연락하다:
- Estrela C Caamaño
- 이메일: estrelacaamano@gmail.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 years or older.
- Scheduled thoracic surgery for pulmonary resection requiring general anesthesia and one-lung ventilation.
- Written informed consent obtained before any study-specific procedure.
Exclusion Criteria:
- Simultaneous participation in another interventional clinical trial that could interfere with the protocol.
- Severe hemodynamic instability before the start of the procedure, defined as continuous vasopressor infusion or shock of any etiology.
- Severe restrictive lung disease, defined as total lung capacity <50% of predicted or forced vital capacity <50% of predicted.
- Body mass index >45 kg/m2.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Fixed PEEP of 4 cmH2O
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Fixed PEEP of 4 cmH2O |
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실험적: BMI-adjusted PEEP calculated as BMI/3 cmH2O
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BMI-adjusted PEEP calculated as BMI/3 cmH2O |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Driving pressure during the primary T2-T4 window
기간: 20 minutes
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Driving pressure during the primary T2-T4 window, measured at 5, 10, and 20 minutes after initiation of one-lung ventilation and expressed in cmH2O. In conventional volume-controlled ventilation, driving pressure is calculated as plateau pressure minus applied PEEP. In pressure-regulated volume-targeted/volume-guaranteed modes, driving pressure is calculated as total end-inspiratory pressure minus applied PEEP. |
20 minutes
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Respiratory system compliance
기간: At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
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Respiratory system compliance will be calculated at each applicable time point as tidal volume divided by driving pressure and expressed in mL/cmH2O |
At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
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Driving pressure at 60 minutes and at the end of one-lung ventilation
기간: At 60 minutes after initiation of one-lung ventilation, when applicable, and at the end of one-lung ventilation.
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Driving pressure will be assessed at 60 minutes after initiation of one-lung ventilation, when this time point is applicable, and at the actual end of one-lung ventilation, to evaluate the persistence of the physiological effect of the assigned PEEP strategy. |
At 60 minutes after initiation of one-lung ventilation, when applicable, and at the end of one-lung ventilation.
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Estimated mechanical power during one-lung ventilation
기간: At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
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Ventilatory mechanical power will be estimated from prospectively recorded ventilatory parameters using a prespecified calculation method appropriate to the ventilation mode and expressed in J/min. |
At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
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Incidence of intraoperative hypoxemia during one-lung ventilation
기간: From initiation until completion of one-lung ventilation during the surgical procedure on Day 1 (up to 1 day).
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Intraoperative hypoxemia will be defined as SpO2 <90% sustained for at least 60 seconds during one-lung ventilation with baseline FiO2 0.6, or any episode of SpO2 <90% requiring immediate clinical intervention at the discretion of the attending anesthesiologist. |
From initiation until completion of one-lung ventilation during the surgical procedure on Day 1 (up to 1 day).
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Incidence of major ventilatory rescue
기간: During the first 20 minutes after initiation of one-lung ventilation on Day 1.
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Major ventilatory rescue during the first 20 minutes after initiation of one-lung ventilation will be defined as any intervention that substantially modifies the assigned ventilatory strategy or respiratory mechanics, including modification of PEEP from the assigned value, recruitment maneuver, CPAP to the non-ventilated lung, temporary restoration of two-lung ventilation, or protocol interruption for safety reasons. |
During the first 20 minutes after initiation of one-lung ventilation on Day 1.
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Incidence of intraoperative hypotension
기간: Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
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Intraoperative hypotension will be defined as mean arterial pressure <65 mmHg sustained for more than 1 minute. |
Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
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Requirement for intraoperative vasopressor support
기간: Time Frame: Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
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Proportion of participants requiring vasopressor administration during the intraoperative period. Vasopressor use will be recorded as a measure of the hemodynamic safety of the assigned PEEP strategy. |
Time Frame: Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
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Incidence of postoperative pulmonary complications
기간: From the end of surgery until hospital discharge during the index hospitalization (estimated average duration: 3-10 days).
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Occurrence of at least one prespecified postoperative pulmonary complication, including acute respiratory failure, pneumonia, acute respiratory distress syndrome, atelectasis, pneumothorax, bronchopleural fistula, aspiration pneumonitis, pulmonary embolism, pleural empyema, bronchospasm, pleural effusion, or need for postoperative respiratory support or reintubation for respiratory deterioration. This outcome will be considered exploratory. |
From the end of surgery until hospital discharge during the index hospitalization (estimated average duration: 3-10 days).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- SIMPLE-PEEP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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