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Clinical Trials/NL-OMON48913
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

Academisch Medisch Centrum0 sites250 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
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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