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

PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02963025
Enrollment
2200
Registered
2016-11-15
Start date
2017-01-31
Completion date
2024-08-31
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One-Lung Ventilation

Keywords

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

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.

Interventions

PROCEDUREPEEP level
PROCEDUREUse of recruitment maneuvers

Sponsors

Istanbul University
CollaboratorOTHER
European Society of Anaesthesiology and Intensive Care
CollaboratorOTHER
Technische Universität Dresden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
The proportion of patients developing one or more postoperative pulmonary complications90 days

Countries

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 (Türkiye), United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026