Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy
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|ClinicalTrials.gov Identifier: NCT03177564|
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment|
|Pulmonary Complication Thoracic Surgery||Procedure: Protective ventilation 1 Procedure: Protective ventilation 2 Procedure: Driving Pressure Limited Ventilation|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy|
|Actual Study Start Date :||June 5, 2017|
|Estimated Primary Completion Date :||June 10, 2018|
|Estimated Study Completion Date :||June 10, 2018|
Active Comparator: Protective Ventilation 1
Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of100%.
Procedure: Protective ventilation 1
Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.
Active Comparator: Protective Ventilation 2
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 5cmH2O and a FiO2 of 60% with lung recruitment maneuvers.
Procedure: Protective ventilation 2
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
Experimental: Driving Pressure Limited Ventilation
The intervention arm receives driving pressure limited ventilation during one-lung ventilation
Procedure: Driving Pressure Limited Ventilation
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 3 to 10 cmH2O during one-lung ventilation and a FiO2 of 60%
- The incidence of postoperative pulmonary complications [ Time Frame: within the first 3 days after surgery ]Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.
- Partial pressure of oxygen in arterial blood [ Time Frame: 15 min after induction, 20 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery ]
- respiratory compliance [ Time Frame: during surgery ]Dynamic compliance, Static compliance
- TNF-α [ Time Frame: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation ]
- IL-8 [ Time Frame: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation ]
- ICU mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
- In-hospital mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
- 28-day survival [ Time Frame: From day 0 to day 28 ]
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): NCT03177564
|Contact: Liu gongjian, M.D/Ph.Dfirstname.lastname@example.org|
|The Affiliated Hospital of Xuzhou Medical University||Recruiting|
|Xuzhou, Jiangsu, China, 221000|
|Contact: Liu gongjian, M.D/Ph.D +86-13952203528 email@example.com|