One-Lung Ventilation Clinical Trial
Official title:
PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial
Verified date | March 2024 |
Source | Technische Universität Dresden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP). Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV. Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.
Status | Active, not recruiting |
Enrollment | 2200 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery) - BMI < 35 kg/m2 - age = 18 years - expected duration of surgery > 60 min - planned lung separation with double lumen tube (DLT, not for study purpose only) - most of ventilation time during surgery expected to be in OLV Exclusion Criteria: - COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax - uncontrolled asthma - Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4 - previous lung surgery - documented pulmonary arterial hypertension >25mmHg MPAP at rest or > 40 mmHg syst. (estimated by ultrasound) - documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others) - planned mechanical ventilation after surgery - bilateral procedures - lung separation with other method than DLT (e.g. difficult airway, tracheostomy) - surgery in prone position - persistent hemodynamic instability, intractable shock - intracranial injury or tumor - enrollment in other interventional study or refusal of informed consent - pregnancy (excluded by anamnesis and/or laboratory analysis) - esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation - presence before induction of anaesthesia of one of the adverse events, listed as postoperative pulmonary complications (aspiration, moderate respiratory failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary edema, pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung hemorrhage) - documented preoperative hypercapnia > 45mmHg (6kPa) |
Country | Name | City | State |
---|---|---|---|
Albania | American Hospital Tirana | Tirana | |
Austria | Medical University of Vienna | Vienna | |
Brazil | Hospital de Amor, Barretos | Barretos | |
Brazil | Clinics Hospital from the Botucatu Medical School, University of Sao Paulo State | São Paulo | |
Brazil | Sao Paulo Hospital | São Paulo | |
Chile | Pontificia Universidad Catolica de Chile | Santiago de Chile | |
China | First Affiliated Hospital of Guangzhou Medical University, China | Guangzhou | |
China | Anhui Provincial Hospital, First Aff. Hospital, University of Science and Technology of China | Hefei | |
China | Fudan University, Shanghai Cancer Center | Shanghai | |
China | Zhongshan Hospital Fudan University | Shanghai | |
China | West China Hospital Sichuan | Sichuan | |
Croatia | University Hospital Dubrava | Zagreb | |
Croatia | University Hospital Zagreb | Zagreb | |
Cyprus | Evangelistria Medical Center, Cyprus | Egkomi | |
Czechia | General University Hospital | Prag | |
Egypt | Mansoura University Hospitals, Egypt | Mansoura | |
Egypt | Tanta University Hospital | Tanta | |
France | University Hospital of Dijon - François Mitterrand | Dijon | |
Germany | University Hospital Aachen | Aachen | |
Germany | Fachkrankenhaus Coswig | Coswig | |
Germany | Department of Anesthesiology and Intensive Care, Dresden University of Technology | Dresden | |
Germany | University Hospital Freiburg | Freiburg | |
Germany | University Hospital Goettingen, Germany | Göttingen | |
Germany | University Hospital Magdeburg | Magdeburg | |
Germany | LMU Muenchen | München | |
Greece | Attikon University Hospital | Athens | |
Greece | Sotiria Chest Hospital | Athens | |
Greece | University Hospital of Heraklion | Heraklion | |
Greece | Patras University Hospital | Patras | |
Hungary | University of Debrecen, Department of anesthesiology and Intensive Care | Debrecen | |
Iraq | Azadi Heart Center, Iraq | Dihok | |
Italy | Arcispedale Sant'Anna | Ferrara | |
Italy | OORR Foggia, University of Foggia | Foggia | |
Italy | Ospedale Policlinico San Martino | Genova | |
Italy | AOU G.Martino | Messina | |
Italy | University Hospital Vanvitelli | Naples | |
Italy | University Hospital of Parma | Parma | |
Italy | University School of Medicine Campus Bio-Medico of Rome | Rome | |
Italy | University-Hospital of Udine | Udine | |
Japan | Juntendo University Hospital | Tokyo | |
Latvia | Riga East University Hospital, Riga, Latvia | Riga | |
Mexico | Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico | Tlalpan | |
Netherlands | Academic Medical Center Amsterdam | Amsterdam | |
Netherlands | VU medical center Amsterdam | Amsterdam | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Radboud University Medical Centre Nijmegen | Nijmegen | |
Romania | Institutul de Pneumoftiziologie Bucharest | Bucharest | |
Saudi Arabia | Department of Anesthesia, College of Medicine, King Saud University Medical City, Saudi-Arabia | Riyadh | |
Serbia | University Clinical centre of Serbia, Serbia | Belgrad | |
Serbia | Military Medical Academy | Belgrade | |
Serbia | Clinical Center Nis, Clinic for anesthesia and intensive therapy | Niš | |
Serbia | University of Novi Sad, Serbia | Novi Sad | |
Slovenia | University Medical Centre Ljubljana | Lubiana | |
Spain | Hospital Clínic. Universitat de Barcelona | Barcelona | |
Spain | Insular Hospital, Gran Canaria, Spain | Las Palmas De Gran Canaria | |
Spain | Hospital General Universitario de Valencia | Valencia | |
Spain | Hospital Universitario de La Ribera | Valencia | |
Spain | Hospital Álvaro Cunqueiro | Vigo | |
Switzerland | University Hospital of Geneva | Geneva | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Turkey | Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital | Ankara | |
Turkey | Ankara University Medical Faculty | Ankara | |
Turkey | University of Health Sciences, Bakirköy Dr. Sadi Konuk Training and Research Hospital, Turkey | Bakirköy | |
Turkey | Acibadem Mehmet Ali Aydinlar University | Istanbul | |
Turkey | Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital | Istanbul | |
Turkey | Istanbul University | Istanbul | |
Turkey | Marmara University Medical Faculty | Istanbul | |
Turkey | University of Health Science, Konya City Hospital, Turkey | Konya | |
Turkey | Celal Bayar University Medical Faculty, Dept of Anesthesiology | Manisa | |
Turkey | Mersin University Medical Faculty | Mersin | |
Turkey | Pamukkale University Dinizli | Pamukkale | |
United Kingdom | University Hospitals Bristol NHS Foundation Trust | Bristol | |
United Kingdom | Golden Jubilee National Hospital | Clydebank | |
United Kingdom | University Hospitals of Leicester | Leicester | |
United Kingdom | St George's Hospital London | London | |
United Kingdom | NIHS Sheffield Clinical Research Facility | Sheffield | |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Cleveland Clinic, USA | Cleveland | Ohio |
United States | NYC Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden | European Society of Anaesthesiology and Intensive Care, Istanbul University |
United States, Albania, Austria, Brazil, Chile, China, Croatia, Cyprus, Czechia, Egypt, France, Germany, Greece, Hungary, Iraq, Italy, Japan, Latvia, Mexico, Netherlands, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Taiwan, Turkey, United Kingdom,
Kiss T, Wittenstein J, Becker C, Birr K, Cinnella G, Cohen E, El Tahan MR, Falcao LF, Gregoretti C, Granell M, Hachenberg T, Hollmann MW, Jankovic R, Karzai W, Krassler J, Loop T, Licker MJ, Marczin N, Mills GH, Murrell MT, Neskovic V, Nisnevitch-Savarese Z, Pelosi P, Rossaint R, Schultz MJ, Serpa Neto A, Severgnini P, Szegedi L, Vegh T, Voyagis G, Zhong J, Gama de Abreu M, Senturk M; PROTHOR investigators; Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA). Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):213. doi: 10.1186/s13063-019-3208-8. Erratum In: Trials. 2019 May 8;20(1):259. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients developing one or more postoperative pulmonary complications | 90 days |
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