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

Completed · Not applicable

Conditions studied: One-Lung Ventilation

In brief

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.

Key facts

Study ID

NCT02963025

Run by

Technische Universität Dresden

People needed

2200

Starts

2017-01-01

Expected to finish

2024-08-01

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• NYC Cornell Medical College — New York, New York, United States
• Cleveland Clinic, USA — Cleveland, Ohio, United States
• American Hospital Tirana — Tirana, Albania
• Medical University of Vienna — Vienna, Austria
• 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, 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
• West China Hospital Sichuan — Sichuan, China
• University Hospital Dubrava — Zagreb, Croatia
• University Hospital Zagreb — Zagreb, Croatia
• Evangelistria Medical Center, Cyprus — Égkomi, Cyprus
• General University Hospital — Prague, Czechia
• Mansoura University Hospitals, Egypt — Al Mansurah, Egypt
• Tanta University Hospital — Tanta, Egypt
• University Hospital of Dijon - François Mitterrand — Dijon, France
• 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 im Breisgau, Germany
• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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