NL-OMON48913RecruitingNot Applicable
PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery - PROTHOR: A randomized controlled trial - The PROTHOR Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 250
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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)
Investigators
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