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 10, 2022
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2024|
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
- The proportion of patients developing one or more postoperative pulmonary complications [ Time Frame: 90 days ]
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
|Contact: Mert Sentürkemail@example.com|
|Contact: Jakob Wittensteinfirstname.lastname@example.org|
|Principal Investigator:||Mert Sentürk||Istanbul University Hospital|