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

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ClinicalTrials.gov Identifier: NCT02963025
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
Istanbul University
Information provided by (Responsible Party):
Technische Universität Dresden

Brief 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.


Condition or disease Intervention/treatment Phase
One-Lung Ventilation Procedure: PEEP level Procedure: Use of recruitment maneuvers Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial
Study Start Date : January 2017
Estimated Primary Completion Date : November 2020

Arm Intervention/treatment
THE HIGHER PEEP LEVEL
Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 10 cmH2O with lung recruitment maneuvers
Procedure: PEEP level
Procedure: Use of recruitment maneuvers
THE LOWER PEEP LEVEL
Mechanical ventilation with VT of 5 ml/kg PBW and the level of PEEP at 5 cmH2O without lung recruitment maneuvers
Procedure: PEEP level



Primary Outcome Measures :
  1. The proportion of patients developing one or more postoperative pulmonary complications [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963025


Contacts
Contact: Mert Sentürk senturkm@istanbul.edu.tr
Contact: Thomas Kiss thomas.kiss@uniklinikum-dresden.de

Locations
Germany
Department of Anesthesiology and Intensive Care, Dresden University of Technology Recruiting
Dresden, Germany, 01307
Contact: Thomas Kiss       thomas.kiss@uniklinikum-dresden.de   
Contact: Marcelo Gama de Abreu       mgabreu@uniklinikum-dresden.de   
Principal Investigator: Marcelo Gama de Abreu         
Turkey
Istanbul University Recruiting
Istanbul, Turkey
Contact: Merk Sentürk       senturkm@istanbul.edu.tr   
Sponsors and Collaborators
Technische Universität Dresden
Istanbul University

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02963025     History of Changes
Other Study ID Numbers: EK 392092016
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No