Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery
2026년 5월 24일 업데이트: Dr. Martin Dworschak, Medical University of Vienna
Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications
This study investigates if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
45
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Martin Dworschak, MD, MBA
- 전화번호: 41090 +43-1-40400
- 이메일: martin.dworschak@meduniwien.ac.at
연구 연락처 백업
- 이름: Edda M. Tschernko, MD, MBA
- 전화번호: 41060 +43-1-40400
- 이메일: edda.tschernko@meduniwien.ac.at
연구 장소
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State of Vienna
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Vienna, State of Vienna, 오스트리아, 1090
- General Hospital Vienna
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연락하다:
- Martin Dworschak, MD, MBA
- 전화번호: 41090 +43-1-40400
- 이메일: martin.dworschak@meduniwien.ac.at
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연락하다:
- Edda M. Tschernko, MD, MBA
- 전화번호: 41060 +43-1-40400
- 이메일: edda.tschernko@meduniwien.ac.at
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수석 연구원:
- Martin Dworschak, MD, MBA
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부수사관:
- Edda M. Tschernko, MD, MBA
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부수사관:
- Keso Skhirtladze-Dworschak, MD
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부수사관:
- Florentina Zingher, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients at increased risk for postoperative pulmonary complications
- Major elective cardiac surgery
- Prolonged duration of cardiopulmonary bypass
- Patients older than 65 years of age
- Informed consent
Exclusion Criteria:
- Emergency
- Urgent procedures
- Patients with implanted pacemakers
- Patients with internal cardioverter/defibrillators
- Decompensated cardiac disease
- Pulmonary disease
- Recent pneumonia
- Need for temporary perioperative mechanical support
- Patients not willing to participate
- Treatment with inhaled nitric oxide
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Risk group
Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube.
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This lung will be ventilated during cardiopulmonary bypass using volume-controlled ventilation with a tidal volume of 3 mL/kg ideal body weight, a PEEP of 5 cmH2O, a respiratory rate of 10/min, and a fraction of inspired oxygen of 30%.
The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Lung aeration score of both lungs.
기간: Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.
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The aeration score of each lung is the sum of the aeration scores determined in each of six lung quadrants in each lung, which can range from 0 (normal ventilation) to 3 (atelectasis/consolidation).
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Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Radiologic assessment of Kerley B lines as indicators of lung edema.
기간: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
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Number of Kerley B lines in both lungs determined by chest x-ray where stage 1 (no Kerley B lines) reflects best outcome, stage 2 (Kerley B lines become visible) indicates interstitial edema, and stage 3 (increased number of Kerley B lines also in non-dependent areas and partially obscured in dependent parts of the lung) are a sign of alveolar edema.
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Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
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Presence of pleural effusion in chest x-ray.
기간: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
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Severity assessment will be semi-quantitative with 0 = no effusion, 1 = small effusion (with blunting of the basal lung segments and the costophrenic angle), 2 = moderate effusion (fluid extents to the mid-hemithorax creating a "meniscus sign"), and 3 = massive effusion (the whole lung appears opaque with displacement of the heart to the contralateral side if located unilaterally).
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Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
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Determination of the Global Inhomogeneity (GI) index in both lungs separately by thoracic Electrical Impedance Tomography (EIT).
기간: On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
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Global inhomogeneity is calculated as the sum of the absolute differences between the median value of tidal variation and every single pixel value, divided by the sum of all impedance values, to normalize the calculated values.
A GI index closer to 0 represents highly homogeneous (even) ventilation.
Higher values (i.e., > 0.5) indicate that some parts of the lung are over-distended while others are poorly aerated or collapsed (atelectasis).
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On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
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Worst oxygenation (Horowitz) index measured per day during routine blood gas checks.
기간: Assessed on the day of surgery and on day 1 and 2 after surgery.
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The Horowitz index (HI) is calculated by diving arterial oxygen partial pressure determined in the blood gas by the fraction of inspired oxygen.
It will be assessed after each blood gas check and the lowest HI during one day will be entered for further statistical analysis.
The degree of impaired lung function will be determined as follows: HI > 300 mmHg (healthy lung function), HI between 201-300 mmHg (mild lung injury), HI between 101-200 mmHg (moderately severely impaired lung function), and HI < 100 mmHg (severe lung injury, ARDS).
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Assessed on the day of surgery and on day 1 and 2 after surgery.
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Static lung compliance determined in each lung separately.
기간: On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
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Static lung compliance of the ventilated and the non-ventilated lung will be determined twice for each patient.
Static compliance in healthy adults ranges between 60 and 100 mL/cm H₂O.
Values below 50 mL/cm H₂O would be considered abnormally low.
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On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
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Amount of released immune modulators.
기간: Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.
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Serum levels for HSP70, MMP-8, MMP-9, TIMP-1, and Lipocalin-2 will be determined in patients' blood samples, with normal values ranging from 0.2-3 ng/mL for HSP70, 0.3-1.2
ng/mL for MMP-8, 14-100 ng/mL for MMP-9, 80-150 ng/mL for TIMP-1, and 20-130 ng/mL for Lipocalin-2, respectively.
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Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Length of ICU and hospital stay.
기간: These variables will be censored at study completion, on average 30 days.
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The duration from transfer to the intensive care unit until discharge to a step-down unit and the duration of hospitalization of the patient will be determined in days.
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These variables will be censored at study completion, on average 30 days.
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In-hospital mortality.
기간: In-hospital mortality will be censored at study completion, on average 30 days.
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It will be recorded if the patient has been discharged from the hospital alive.
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In-hospital mortality will be censored at study completion, on average 30 days.
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Duration on respiratory support via endotracheal tube.
기간: The time until extubation will be censored at study completion, on average 30 days.
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The hours between arrival of the intubated patient on the intensive care unit until extubation will be determined.
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The time until extubation will be censored at study completion, on average 30 days.
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Postoperative complications.
기간: All complications will be censored at study completion, on average 30 days.
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Any complication that poses a risk for the patient occurring during the hospital stay and having been documented in the patient's file will be retrieved by carefully reviewing the files and recorded.
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All complications will be censored at study completion, on average 30 days.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Martin Dworschak, MD, MBA, Medical University of Vienna
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2028년 12월 31일
연구 완료 (추정된)
2029년 7월 31일
연구 등록 날짜
최초 제출
2026년 4월 4일
QC 기준을 충족하는 최초 제출
2026년 5월 24일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 24일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EK Nr: 1250/2021
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
The primary reason for not sharing IPD is the protection of patient privacy.
약물 및 장치 정보, 연구 문서
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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