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

Not Applicable

Active, not recruiting

• Conditions: One-Lung Ventilation
• Interventions: Procedure: PEEP level; Procedure: Use of recruitment maneuvers

• Registration Number: NCT02963025
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Study Start: 2017-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THE HIGHER PEEP LEVEL	PEEP level	Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers
THE HIGHER PEEP LEVEL	Use of recruitment maneuvers	Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers
THE LOWER PEEP LEVEL	PEEP level	Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 5 cmH2O without lung recruitment maneuvers

Primary Outcome Measures

Name	Time	Method
The proportion of patients developing one or more postoperative pulmonary complications	90 days

Trial Locations

Locations (79)

University Medical Centre Ljubljana; 🇸🇮 Lubiana, Slovenia

Riga East University Hospital, Riga, Latvia; 🇱🇻 Riga, Latvia

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland

American Hospital Tirana; 🇦🇱 Tirana, Albania

Medical University of Vienna; 🇦🇹 Vienna, Austria

Attikon University Hospital; 🇬🇷 Athens, Greece

Istanbul University; 🇹🇷 Istanbul, Turkey

West China Hospital Sichuan; 🇨🇳 Sichuan, China

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

NYC Cornell Medical College; 🇺🇸 New York, New York, United States

Cleveland Clinic, USA; 🇺🇸 Cleveland, Ohio, United States

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, Brazil

Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago de Chile, Chile

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

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia

University Hospital Zagreb; 🇭🇷 Zagreb, Croatia

Mansoura University Hospitals, Egypt; 🇪🇬 Mansoura, Egypt

Evangelistria Medical Center, Cyprus; 🇨🇾 Egkomi, Cyprus

University Hospital Aachen; 🇩🇪 Aachen, Germany

University Hospital of Dijon - François Mitterrand; 🇫🇷 Dijon, France

General University Hospital; 🇨🇿 Prag, Czechia

Tanta University Hospital; 🇪🇬 Tanta, Egypt

Fachkrankenhaus Coswig; 🇩🇪 Coswig, Germany

University Hospital Goettingen, Germany; 🇩🇪 Göttingen, Germany

Department of Anesthesiology and Intensive Care, Dresden University of Technology; 🇩🇪 Dresden, Germany

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

University Hospital Magdeburg; 🇩🇪 Magdeburg, Germany

LMU Muenchen; 🇩🇪 München, Germany

Patras University Hospital; 🇬🇷 Patras, Greece

Sotiria Chest Hospital; 🇬🇷 Athens, Greece

University Hospital of Heraklion; 🇬🇷 Heraklion, Greece

University of Debrecen, Department of anesthesiology and Intensive Care; 🇭🇺 Debrecen, Hungary

Azadi Heart Center, Iraq; 🇮🇶 Dihok, Iraq

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, Italy

Juntendo University Hospital; 🇯🇵 Tokyo, Japan

Academic Medical Center Amsterdam; 🇳🇱 Amsterdam, Netherlands

VU medical center Amsterdam; 🇳🇱 Amsterdam, Netherlands

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico; 🇲🇽 Tlalpan, Mexico

Radboud University Medical Centre Nijmegen; 🇳🇱 Nijmegen, Netherlands

Institutul de Pneumoftiziologie Bucharest; 🇷🇴 Bucharest, Romania

Department of Anesthesia, College of Medicine, King Saud University Medical City, Saudi-Arabia; 🇸🇦 Riyadh, Saudi Arabia

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Clinical Center Nis, Clinic for anesthesia and intensive therapy; 🇷🇸 Niš, Serbia

University Clinical centre of Serbia, Serbia; 🇷🇸 Belgrad, Serbia

Military Medical Academy; 🇷🇸 Belgrade, Serbia

University of Novi Sad, Serbia; 🇷🇸 Novi Sad, Serbia

Hospital Clínic. Universitat de Barcelona; 🇪🇸 Barcelona, Spain

Insular Hospital, Gran Canaria, Spain; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario de La Ribera; 🇪🇸 Valencia, Spain

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Ankara University Medical Faculty; 🇹🇷 Ankara, Turkey

Acıbadem Mehmet Ali Aydınlar University; 🇹🇷 Istanbul, Turkey

Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital; 🇹🇷 Ankara, Turkey

Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital; 🇹🇷 Istanbul, Turkey

University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey; 🇹🇷 Bakırköy, Turkey

University of Health Science, Konya City Hospital, Turkey; 🇹🇷 Konya, Turkey

Marmara University Medical Faculty; 🇹🇷 Istanbul, Turkey

Celal Bayar University Medical Faculty, Dept of Anesthesiology; 🇹🇷 Manisa, Turkey

Mersin University Medical Faculty; 🇹🇷 Mersin, Turkey

Pamukkale University Dinizli; 🇹🇷 Pamukkale, Turkey

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 Kingdom