Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02963025
• Other study ID #: EK 392092016
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• One-Lung Ventilation

Intervention

Procedure:
• PEEP level

• Use of recruitment maneuvers

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	European Society of Anaesthesiology and Intensive Care, Istanbul University

Countries where clinical trial is conducted

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, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients developing one or more postoperative pulmonary complications		90 days

External Links

•   Trial Website