The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 21, 2016
June 1, 2012
1.7 years
June 21, 2012
April 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Levels of IL-8, TNFa in the bronchoalveolar lavage
up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
Secondary Outcomes (4)
Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage
up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
oxygenation
1 hour after extubation
Chest-X ray
7 days after surgery
Study Arms (3)
conventional
NO INTERVENTIONTwo-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP
Protective
ACTIVE COMPARATORTwo-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.
Recruitment
ACTIVE COMPARATORTwo-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation.
Interventions
Low tidal volume, PEEP and recruitment maneuver
Eligibility Criteria
You may qualify if:
- Years and older
- Patients undergoing thoracic surgery
You may not qualify if:
- Emergency surgery
- Heart failure
- Pulmonary hypertension
- Forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values
- Coagulation disorder
- Pulmonary or extrapulmonary infections
- History of treatment with steroid in 3 months before surgery
- History of recurrent pneumothorax
- History of lung resection surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 28, 2012
Study Start
June 1, 2012
Primary Completion
March 1, 2014
Study Completion
May 1, 2014
Last Updated
April 21, 2016
Record last verified: 2012-06