ClinicalTrials.gg
CompletedNCT02963025Updated Sep 26, 2025

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

An interventional study of PEEP level and Use of recruitment maneuvers in One-Lung Ventilation, sponsored by Technische Universität Dresden. Completed at 79 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • One-Lung Ventilation

Keywords

  • Mechanical ventilation
  • positive end-expiratory pressure
  • recruitment maneuver
  • one-lung ventilation
  • thoracic surgery
  • postoperative pulmonary complication
03

In context

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
  • \< 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

Exclusion Criteria:

  • GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax
  • uncontrolled asthma
  • Heart failure 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
  • 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)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
2,200 participants (actual)

Study arms

  • Other
    THE HIGHER PEEP LEVEL

    Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers

    Procedure: PEEP level · Procedure: Use of recruitment maneuvers

  • Other
    THE LOWER PEEP LEVEL

    Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 5 cmH2O without lung recruitment maneuvers

    Procedure: PEEP level

Interventions

  • ProcedurePEEP level
  • ProcedureUse of recruitment maneuvers
06

What researchers measure

Primary outcomes

  1. The proportion of patients developing one or more postoperative pulmonary complications

    Time frame: 90 days

07

Study locations

79 sites
  • Tufts Medical Center
    Boston, Massachusetts, United States
  • 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, 01307, Germany
  • University Hospital Freiburg
    Freiburg im Breisgau, Germany
  • University Hospital Goettingen, Germany
    Göttingen, Germany
  • University Hospital Magdeburg
    Magdeburg, Germany
  • LMU Muenchen
    München, Germany
  • Attikon University Hospital
    Athens, Greece
  • Sotiria Chest Hospital
    Athens, Greece
  • University Hospital of Heraklion
    Heraklion, Greece
  • Patras University Hospital
    Pátrai, Greece
  • University of Debrecen, Department of anesthesiology and Intensive Care
    Debrecen, Hungary
  • Azadi Heart Center, Iraq
    Duhok, 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
  • Riga East University Hospital, Riga, Latvia
    Riga, Latvia
  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico
    Tlalpan, Mexico
  • Academic Medical Center Amsterdam
    Amsterdam, Netherlands
  • VU medical center Amsterdam
    Amsterdam, Netherlands
  • Rijnstate Hospital
    Arnhem, Netherlands
  • 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
  • Military Medical Academy
    Belgrade, Serbia
  • University Clinical centre of Serbia, Serbia
    Belgrade, Serbia
  • Clinical Center Nis, Clinic for anesthesia and intensive therapy
    Niš, Serbia
  • University of Novi Sad, Serbia
    Novi Sad, Serbia
  • University Medical Centre Ljubljana
    Ljubljana, Slovenia
  • 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, Spain
  • University Hospital of Geneva
    Geneva, Switzerland
  • Taichung Veterans General Hospital
    Taichung, Taiwan
  • Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital
    Ankara, Turkey (Türkiye)
  • Ankara University Medical Faculty
    Ankara, Turkey (Türkiye)
  • University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey
    Bakırköy, Turkey (Türkiye)
  • Acıbadem Mehmet Ali Aydınlar University
    Istanbul, Turkey (Türkiye)
  • Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital
    Istanbul, Turkey (Türkiye)
  • Istanbul University
    Istanbul, Turkey (Türkiye)
  • Marmara University Medical Faculty
    Istanbul, Turkey (Türkiye)
  • University of Health Science, Konya City Hospital, Turkey
    Konya, Turkey (Türkiye)
  • Celal Bayar University Medical Faculty, Dept of Anesthesiology
    Manisa, Turkey (Türkiye)
  • Mersin University Medical Faculty
    Mersin, Turkey (Türkiye)
  • Pamukkale University Dinizli
    Pamukkale, Turkey (Türkiye)
  • 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
08

References and documents

Publications

  • 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. PubMed 30975217 ↗
  • Writing Committee; Steering Committee; PROTHOR Collaborative Group; PROtective VEntilation Network (PROVE Network) for the Clinical Trial Network of the European Society of Anaesthesiology and Intensive Care. Effects of intraoperative higher versus lower positive end-expiratory pressure during one-lung ventilation for thoracic surgery on postoperative pulmonary complications (PROTHOR): a multicentre, international, randomised, controlled, phase 3 trial. Lancet Respir Med. 2026 Jan;14(1):17-28. doi: 10.1016/S2213-2600(25)00330-3. Epub 2025 Nov 12. PubMed 41240959 ↗

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02963025
Collaborators
Istanbul University, European Society of Anaesthesiology and Intensive Care
Responsible party
Sponsor
First posted
Nov 15, 2016
Start date
Jan 2017
Primary completion
Aug 2024
Completion
Aug 2024
Last update
Sep 26, 2025

Study contacts

Mert Sentürk
principal investigator · Istanbul University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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