One-Lung VentilationNCT02963025
Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery
A study testing PEEP level and Use of recruitment maneuvers in people with One-Lung Ventilation, run by Technische Universität Dresden at 79 sites in 29 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-Lung Ventilation
- What is being tested?
- PEEP level and Use of recruitment maneuvers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 79 sitesin 29 countries
- Study dates
- Jan 2017to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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)
Trial locations and contacts
79 sites in 29 countries.
79 sites in 29 countries
Turkey (Türkiye)11 sites
Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital
Ankara
Ankara University Medical Faculty
Ankara
University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey
Bakırköy
Acıbadem Mehmet Ali Aydınlar University
Istanbul
Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital
Istanbul
Istanbul University
Istanbul
Marmara University Medical Faculty
Istanbul
University of Health Science, Konya City Hospital, Turkey
Konya
Celal Bayar University Medical Faculty, Dept of Anesthesiology
Manisa
Mersin University Medical Faculty
Mersin
Pamukkale University Dinizli
Pamukkale
Italy8 sites
Arcispedale Sant'Anna
Ferrara
OORR Foggia, University of Foggia
Foggia
Ospedale Policlinico San Martino
Genova
AOU G.Martino
Messina
University Hospital Vanvitelli
Naples
University Hospital of Parma
Parma
University School of Medicine Campus Bio-Medico of Rome
Rome
University-Hospital of Udine
Udine
Germany7 sites
University Hospital Aachen
Aachen
Fachkrankenhaus Coswig
Coswig
Department of Anesthesiology and Intensive Care, Dresden University of Technology
Dresden, 01307
University Hospital Freiburg
Freiburg im Breisgau
University Hospital Goettingen, Germany
Göttingen
University Hospital Magdeburg
Magdeburg
LMU Muenchen
München
China5 sites
First Affiliated Hospital of Guangzhou Medical University, China
Guangzhou
Anhui Provincial Hospital, First Aff. Hospital, University of Science and Technology of China
Hefei
Fudan University, Shanghai Cancer Center
Shanghai
Zhongshan Hospital Fudan University
Shanghai
West China Hospital Sichuan
Sichuan
Spain5 sites
Hospital Clínic. Universitat de Barcelona
Barcelona
Insular Hospital, Gran Canaria, Spain
Las Palmas de Gran Canaria
Hospital General Universitario de Valencia
Valencia
Hospital Universitario de La Ribera
Valencia
Hospital Álvaro Cunqueiro
Vigo
United Kingdom5 sites
University Hospitals Bristol NHS Foundation Trust
Bristol
Golden Jubilee National Hospital
Clydebank
University Hospitals of Leicester
Leicester
St George's Hospital London
London
NIHS Sheffield Clinical Research Facility
Sheffield
Greece4 sites
Attikon University Hospital
Athens
Sotiria Chest Hospital
Athens
University Hospital of Heraklion
Heraklion
Patras University Hospital
Pátrai
Netherlands4 sites
Academic Medical Center Amsterdam
Amsterdam
VU medical center Amsterdam
Amsterdam
Rijnstate Hospital
Arnhem
Radboud University Medical Centre Nijmegen
Nijmegen
Serbia4 sites
Military Medical Academy
Belgrade
University Clinical centre of Serbia, Serbia
Belgrade
Clinical Center Nis, Clinic for anesthesia and intensive therapy
Niš
University of Novi Sad, Serbia
Novi Sad
United States3 sites
Tufts Medical Center
Boston, Massachusetts
Cleveland Clinic, USA
Cleveland, Ohio
NYC Cornell Medical College
New York, New York
Brazil3 sites
Hospital de Amor, Barretos
Barretos
Clinics Hospital from the Botucatu Medical School, University of Sao Paulo State
São Paulo
Sao Paulo Hospital
São Paulo
Croatia2 sites
University Hospital Dubrava
Zagreb
University Hospital Zagreb
Zagreb
Egypt2 sites
Mansoura University Hospitals, Egypt
Al Mansurah
Tanta University Hospital
Tanta
Hungary1 site
University of Debrecen, Department of anesthesiology and Intensive Care
Debrecen
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico
Tlalpan
Saudi Arabia1 site
Department of Anesthesia, College of Medicine, King Saud University Medical City, Saudi-Arabia
Riyadh
About this study
Official title: PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial
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.
- Conditions
- One-Lung Ventilation
- Being tested
- PEEP level, Use of recruitment maneuvers
- Keywords
- Mechanical ventilation, positive end-expiratory pressure, recruitment maneuver, one-lung ventilation, thoracic surgery, postoperative pulmonary complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP levelProcedure or surgery
Use of recruitment maneuversProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| THE HIGHER PEEP LEVEL | Other | Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers Receives: Procedure: PEEP level; Procedure: Use of recruitment maneuvers |
| THE LOWER PEEP LEVEL | Other | Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 5 cmH2O without lung recruitment maneuvers Receives: Procedure: PEEP level |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients developing one or more postoperative pulmonary complications
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionAug 2024
- Study completionAug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for One-Lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, European Society of Anaesthesiology and Intensive Care
- Responsible party
- Sponsor
- Investigators
- Mert Sentürk, Principal investigator, Istanbul University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963025
- Sponsor's protocol ID
- EK 392092016
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2016
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 30975217Writing 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02963025
- Acronym / sponsor ID
- EK 392092016
- Conditions
- One-Lung Ventilation
- Keywords
- Mechanical ventilation, positive end-expiratory pressure, recruitment maneuver, one-lung ventilation, thoracic surgery, postoperative pulmonary complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Istanbul University, European Society of Anaesthesiology and Intensive Care
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2024 (actual)
- Study completion
- Aug 2024 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THE HIGHER PEEP LEVEL | Other | Procedure: PEEP level, Procedure: Use of recruitment maneuversMechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers |
| THE LOWER PEEP LEVEL | Other | Procedure: PEEP levelMechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 5 cmH2O without lung recruitment maneuvers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP level | Procedure or surgery | THE HIGHER PEEP LEVEL, THE LOWER PEEP LEVEL |
| Use of recruitment maneuvers | Procedure or surgery | THE HIGHER PEEP LEVEL |
Primary outcome
The proportion of patients developing one or more postoperative pulmonary complications
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 30975217Kiss 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.
- Derived from this study: PubMed 41240959Writing 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.
- Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
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Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
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Brief Bronchial Suction for Lung Collapse During Uniportal VATS
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Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mert Sentürk principal investigator
Istanbul University Hospital
79 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP level and Use of recruitment maneuvers in people with One-Lung Ventilation, run by Technische Universität Dresden at 79 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Turkey (Türkiye), Italy, Germany, China, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients developing one or more postoperative pulmonary complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.