- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07660588
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Effect of Brief Bronchial Suction on the Quality of Non-Ventilated Lung Collapse and Time to Adequate Surgical Exposure During Uniportal Video-Assisted Thoracoscopic Surgery: a Randomized Patient- and Surgeon-Blinded Trial
The goal of this clinical trial is to learn whether a brief suction of the airway going to the surgical lung (bronchus) can help the lung collapse faster and more completely during uniportal video-assisted thoracoscopic surgery (UVATS). This type of surgery is performed through a small incision in the chest, and good lung collapse helps the surgeon see and work safely. The main questions it aims to answer are
- Does brief bronchial suction improve the quality of lung collapse 1 minute after chest cavity is opened?
- Does brief bronchial suction help reach satisfactory lung collapse faster?
Researchers will compare patients who receive brief bronchial suction and those who do not. This is to see if suction improves and fastens lung collapse, reduce the need for additional steps if lung is not adequately collapsed, affect inflammation, oxygenation, postoperative pulmonary complications, operative time, and the duration of one-lung ventilation. Participants will
- Undergo UVATS under general anesthesia
- Have a double-lumen breathing tube placed as part of the standard anesthetic care
- Be randomly assigned to either receive bronchial suction for one minute or receive no bronchial suction
- Have the surgical team assess the quality of lung collapse at different time points
- Have blood samples taken for interleukin-6, a marker related to inflammation, once during and once after surgery. These samples are collected through a small tube in a vein that is placed as a standard anesthetic care while the participant is under general anesthesia. No extra puncture is required for blood collection.
- Have information collected from the routine anesthesia and surgical records such as oxygen levels during surgery, length of surgery and lung-related complications within 7 days after surgery
연구 개요
상태
개입 / 치료
상세 설명
Uniportal video-assisted lung surgery (UVATS) is increasingly being performed in many centers. Due to a short interval between the skin incision and pleural opening, a rapid and adequate surgical lung collapse is important for optimal surgical exposure and operative efficiency. Delayed or inadequate lung collapse may interfere with the operative field, increase the need for manual lung manipulation by surgeons and possibly a resultant increase in lung inflammation. Brief bronchial suction through a double lumen tube has been used to facilitate lung collapse although its effectiveness is questionable in three-port VATS. This study aims to investigate if a brief bronchial suction helps achieve a better and faster lung collapse in UVATS.
Study objectives This randomized controlled trial aims to evaluate whether a brief suction through a tube in the non-ventilated lung leads to a better quality of lung collapse at one minute after the surgeon enters the chest. The study will compare the results between patients who receive a brief bronchial suction and those who do not.
Study design This is a randomized controlled trial conducted at a single university hospital in Thailand. Adult patients undergoing UVATS will be enrolled. A double-lumen endotracheal tube will be placed under general anesthesia as part of a standard anesthetic care. Patients will be randomly assigned to either receive a bronchial suction for one minute or no bronchial suction. The intervention group will undergo bronchial suction on two occasions: before pleural opening and immediately after pleural opening. Each suction period will last for 60 seconds.
The quality of lung collapse will be assessed by the surgical team at different time points during the surgery, including one minute after chest opening. Time to satisfactory lung collapse will also be evaluated.
Other perioperative data and outcome including requirement for additional steps in case of inadequate lung collapse, duration of one-lung ventilation, duration of surgery, incidence of intraoperative hypoxemia and postoperative pulmonary complications will also be collected.
To investigate the inflammatory response associated with suction and lung surgery, levels of interleukin-6 will be collected twice during and after surgery through an intravenous access placed under general anesthesia as part of a standard anesthetic care.
Potential significance The findings from this study may help to optimize anesthetic management for patients undergoing VATS, particularly UVATS, and provide evidence on the effectiveness of bronchial suction on the quality and speed of lung collapse. The information may contribute to evidence-based recommendations on intraoperative strategies to improve lung collapse during minimally invasive lung surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nattaya Raykateeraroj, MD
- 전화번호: +66993519963
- 이메일: raykageeraroj@gmail.com
연구 연락처 백업
- 이름: Rattanaporn Tankul, MD
- 전화번호: +66897714345
- 이메일: rattanaporn.tan@mahidol.ac.th
연구 장소
-
-
-
Bangkok, 태국, 10700
- Siriraj Hospital, Mahidol University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥ 18 years old
- BMI ≤ 35 kg/m2
- American Society of Anesthesiologists (ASA) physical status I to III
- Scheduled for elective single-port video-assisted thoracoscopic surgery (VATS) at Siriraj Hospital
- Requirement for one-lung ventilation using a double-lumen tube (DLT)
- Surgery performed in the lateral decubitus position
- Ability to provide written informed consent
Exclusion Criteria:
- Previous thoracic surgery
- Known or suspected severe pleural adhesions based on preoperative imaging or clinical history
- Tracheobronchial anatomical abnormalities
- Pulmonary bullae identified on chest radiography or computed tomography, or a history of recurrent pneumothorax
- Forced vital capacity (FVC) < 50% of predicted
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Bronchial suction
Participants will receive bronchial suction through the operative lumen of the double-lumen endotracheal tube
|
Bronchial suction will be performed through the operative lumen of the double-lumen endobronchial tube on two occasions: before pleural opening, and immediately after pleural opening.
The suction pressure is at -30 cmH2O and each suction period will last for 60 seconds.
|
|
간섭 없음: No bronchial suction
Participants will undergo one-lung ventilation without bronchial suction
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of lung collapse at 1 minute after pleural opening
기간: At 1 minute after pleural opening
|
Surgical team to assess quality of lung collapse at 1 minute after pleural opening by using lung collapse score (LCS).
The higher the LCS, the better the lung collapse.
|
At 1 minute after pleural opening
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of lung collapse at pleural opening, 5 minutes and 10 minutes after pleural opening
기간: At pleural opening, and at 5 and 10 minutes after pleural opening
|
Quality of lung collapse assessed by the surgical team using the Lung Collapse Score (LCS) immediately after pleural opening, and at 5 minutes and 10 minutes after pleural opening.
|
At pleural opening, and at 5 and 10 minutes after pleural opening
|
|
Time to satisfactory lung collapse
기간: From pleural opening until the first LCS of 8 or greater, assessed up to 10 minutes after pleural opening
|
Time from pleural opening to the first Lung Collapse Score (LCS) of 8 or greater
|
From pleural opening until the first LCS of 8 or greater, assessed up to 10 minutes after pleural opening
|
|
Requirement for rescue maneuvers for inadequate lung collapse
기간: From pleural opening until the end of one-lung ventilation during the index surgery up to 6 hours
|
Need for additional intraoperative maneuvers to improve lung collapse due to inadequate surgical exposure
|
From pleural opening until the end of one-lung ventilation during the index surgery up to 6 hours
|
|
Change in interleukin-6 level from baseline to after one-lung ventilation
기간: At baseline after induction of anesthesia and at 30-60 minutes after completion of one-lung ventilation
|
Plasma interleukin-6 level measured at baseline after induction of anesthesia and 30-60 minutes after completion of one-lung ventilation in the post-anesthesia care unit.
|
At baseline after induction of anesthesia and at 30-60 minutes after completion of one-lung ventilation
|
|
Incidence of intraoperative hypoxemia
기간: From initiation of one-lung ventilation until resumption of two-lung ventilation during the index surgery up to 6 hours
|
Occurrence of intraoperative hypoxemia during one-lung ventilation, defined as SpO2 < 90%
|
From initiation of one-lung ventilation until resumption of two-lung ventilation during the index surgery up to 6 hours
|
|
Incidence of postoperative pulmonary complications
기간: From end of surgery through postoperative day 7 or hospital discharge, whichever occurs first
|
Occurrence of postoperative pulmonary complications within 7 days after surgery or until hospital discharge, whichever occurs first.
These include, but are not limited to, atelectasis, pneumonia, pulmonary aspiration, respiratory infection, pleural effusion, pneumothorax, bronchospasm, pulmonary edema, and respiratory failure.
|
From end of surgery through postoperative day 7 or hospital discharge, whichever occurs first
|
|
Total operative duration
기간: From surgical incision to completion of surgery during the index operation, up to 6 hours
|
Duration of surgery measured from surgical incision to completion of surgery.
|
From surgical incision to completion of surgery during the index operation, up to 6 hours
|
|
Duration of one-lung ventilation
기간: From initiation of one-lung ventilation until resumption of two-lung ventilation during the index operation, up to 6 hours
|
Total duration of one-lung ventilation during surgery
|
From initiation of one-lung ventilation until resumption of two-lung ventilation during the index operation, up to 6 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nattaya Raykateeraroj, MD, Siriraj Hospital
간행물 및 유용한 링크
일반 간행물
- Pfitzner J, Peacock MJ, Harris RJ. Speed of collapse of the non-ventilated lung during single-lung ventilation for thoracoscopic surgery: the effect of transient increases in pleural pressure on the venting of gas from the non-ventilated lung. Anaesthesia. 2001 Oct;56(10):940-6. doi: 10.1046/j.1365-2044.2001.02211.x.
- Yoshimura T, Ueda K, Kakinuma A, Sawai J, Nakata Y. Bronchial blocker lung collapse technique: nitrous oxide for facilitating lung collapse during one-lung ventilation with a bronchial blocker. Anesth Analg. 2014 Mar;118(3):666-70. doi: 10.1213/ANE.0000000000000106.
- Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.
- Brassard CL, Lohser J, Donati F, Bussieres JS. Step-by-step clinical management of one-lung ventilation: continuing professional development. Can J Anaesth. 2014 Dec;61(12):1103-21. doi: 10.1007/s12630-014-0246-2. Epub 2014 Nov 12. English, French.
- Reniers T, Noordzij PG, Veen EJ, Hofman EFN, Taselaar AM, Visser WA, van der Heiden P, Boeckx S, Emmen JMA, Dijkstra IM, Cremer OL, Vernooij LM, Rettig TCD. Does postoperative plasma IL-6 improve early prediction of infection after pulmonary cancer surgery? A two-centre prospective study. PLoS One. 2025 Jun 23;20(6):e0326537. doi: 10.1371/journal.pone.0326537. eCollection 2025.
- Neff TA, Braun J, Rana D, Puhan M, Filipovic M, Seeberger M, Stuber F, Neff SB, Beck-Schimmer B, Schlapfer M. Interleukin-6 Is an Early Plasma Marker of Severe Postoperative Complications in Thoracic Surgery: Exploratory Results From a Substudy of a Randomized Controlled Multicenter Trial. Anesth Analg. 2022 Jan 1;134(1):123-132. doi: 10.1213/ANE.0000000000005639.
- Fink-Neuboeck N, Lindenmann J, Bajric S, Maier A, Riedl R, Weinberg AM, Smolle-Juettner FM. Clinical impact of interleukin 6 as a predictive biomarker in the early diagnosis of postoperative systemic inflammatory response syndrome after major thoracic surgery: A prospective clinical trial. Surgery. 2016 Aug;160(2):443-53. doi: 10.1016/j.surg.2016.04.004. Epub 2016 May 17.
- Engels GE, van Oeveren W. Biomarkers of lung injury in cardiothoracic surgery. Dis Markers. 2015;2015:472360. doi: 10.1155/2015/472360. Epub 2015 Mar 17.
- Reinersman JM, Passera E, Rocco G. Overview of uniportal video-assisted thoracic surgery (VATS): past and present. Ann Cardiothorac Surg. 2016 Mar;5(2):112-7. doi: 10.21037/acs.2016.03.08.
- Xiang YY, Chen Q, Tang XX, Cao L. Comparison of the effect of double-lumen endotracheal tubes and bronchial blockers on lung collapse in video-assisted thoracoscopic surgery: a systematic review and meta-analysis. BMC Anesthesiol. 2022 Oct 29;22(1):330. doi: 10.1186/s12871-022-01876-2.
- Quan X, Yi J, Huang Y, Zhang X, Shen L, Li S. Bronchial suction does not facilitate lung collapse when using a double-lumen tube during video-assisted thoracoscopic surgery: a randomized controlled trial. J Thorac Dis. 2017 Dec;9(12):5244-5248. doi: 10.21037/jtd.2017.11.63.
- Zhang Y, Yan W, Fan Z, Kang X, Tan H, Fu H, Li Z, Chen KN, Chen J. Preemptive one lung ventilation enhances lung collapse during thoracoscopic surgery: A randomized controlled trial. Thorac Cancer. 2019 Jun;10(6):1448-1452. doi: 10.1111/1759-7714.13091. Epub 2019 May 21.
- Somma J, Couture EJ, Pelletier S, Provencher S, Moreault O, Lohser J, Ugalde PA, Vigneault L, Lemieux J, Somma A, Guay SE, Bussieres JS. Non-ventilated lung deflation during one-lung ventilation with a double-lumen endotracheal tube: a randomized-controlled trial of occluding the non-ventilated endobronchial lumen before pleural opening. Can J Anaesth. 2021 Jun;68(6):801-811. doi: 10.1007/s12630-021-01957-9. Epub 2021 Apr 2.
- Li Q, Zhang X, Wu J, Xu M. Two-minute disconnection technique with a double-lumen tube to speed the collapse of the non-ventilated lung for one-lung ventilation in thoracoscopic surgery. BMC Anesthesiol. 2017 Jun 15;17(1):80. doi: 10.1186/s12871-017-0371-x.
- Pfitzner J. Facilitating lung collapse during one lung ventilation can be rational. Anesth Analg. 2014 Oct;119(4):1002-1003. doi: 10.1213/ANE.0000000000000336. No abstract available.
- Li Y, Huang H, Hang L. Comparison of efficacy and safety of different suction pressure for speeding non-ventilated lung collapse in uniport video-assisted thoracoscopic surgery: a randomized-controlled trial. BMC Surg. 2024 Sep 3;24(1):247. doi: 10.1186/s12893-024-02539-4.
- Hang L, Ju J, Li Y, He M. The impact of suction duration on lung collapse during one-lung ventilation. Front Surg. 2025 Mar 31;12:1532176. doi: 10.3389/fsurg.2025.1532176. eCollection 2025.
- Bussières JS, Marques E. Atelectasis in one lung ventilation: the good, the bad, and the ugly: a narrative review. Curr Chall Thorac Surg. 2023;5:38.
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
- SIRIRAJ-SUCTION-UVATS-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
한쪽 폐 환기에 대한 임상 시험
-
Ruijin Hospital완전한심각한 병 | 호흡 부전 | 폐관류 | Ventilation-Perfusion Ratio중국
-
Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방
-
Taichung Veterans General Hospital완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제대만
-
Fondazione del Piemonte per l'Oncologia모병유방암 | 난소 암 | 대장암 | 흑색종(피부암) | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung)이탈리아
bronchial suction에 대한 임상 시험
-
University of WashingtonCongressionally Directed Medical Research Programs완전한