CompletedNot Applicable

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

United States, Albania, Austria2,200 participantsStarted 2017-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of patients developing one or more postoperative pulmonary complications

Timeframe: 90 days

Trial details

NCT IDNCT02963025

SponsorTechnische Universität Dresden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08

View on ClinicalTrials.gov More One-Lung Ventilation trials