PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery - PROTHOR: A randomized controlled trial

Recruiting

• Conditions: Mechanical one lung ventilation and post-operative Pulmonary complications; Mechanical ventilation; Lung function; 10069888

• Registration Number: NL-OMON48913
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 250

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients developing one or more PPCs </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• intraoperative complications<br /><br>• postoperative extra-pulmonary complications<br /><br>• extended PPCs<br /><br>• need for unexpected ICU admission or ICU readmission<br /><br>• number of hospital-free days at day 28<br /><br>• 90-day survival<br /><br>• arterial blood gas analysis during OLV, TLV (pCO2, pO2, pH)<br /><br>• any postoperative respiratory intervention (e.g. NIV or CPAP or intubation or<br /><br>High Flow Nasal Cannula)</p><br>