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

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.

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Key information

Conditions

One-Lung Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Hospital Tirana, Tirana, Albania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PEEP level

Procedure

Use of recruitment maneuvers

Procedure

Primary outcomes

The proportion of patients developing one or more postoperative pulmonary complications

Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

European Society of Anaesthesiology and Intensive Care
Istanbul University

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Nov 15, 2016
Registry last updated: Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed