Back to resultsThe Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
Primary Purpose
Mechanical Ventilation Complication, Thoracic Surgery, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
protective ventilation
Recruitment maneuver combined with protective ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Mechanical Ventilation Complication
Eligibility Criteria
Inclusion Criteria:
- 20 Years and older
- Patients undergoing thoracic surgery
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
conventional
Protective
Recruitment
Arm Description
Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP
Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.
Two-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.
Outcomes
Primary Outcome Measures
Levels of IL-8, TNFa in the bronchoalveolar lavage
Secondary Outcome Measures
Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage
plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
oxygenation
Changes in PaO2/FIO2 ratio
Chest-X ray
Full Information
NCT ID
NCT01630395
First Posted
June 21, 2012
Last Updated
April 20, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01630395
Brief Title
The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
Official Title
The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Thoracic Surgery, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional
Arm Type
No Intervention
Arm Description
Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP
Arm Title
Protective
Arm Type
Active Comparator
Arm Description
Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.
Arm Title
Recruitment
Arm Type
Active Comparator
Arm Description
Two-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.
Intervention Type
Procedure
Intervention Name(s)
protective ventilation
Intervention Description
low tidal volume and PEEP
Intervention Type
Procedure
Intervention Name(s)
Recruitment maneuver combined with protective ventilation
Intervention Description
Low tidal volume, PEEP and recruitment maneuver
Primary Outcome Measure Information:
Title
Levels of IL-8, TNFa in the bronchoalveolar lavage
Time Frame
up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
Secondary Outcome Measure Information:
Title
Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage
Time Frame
up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
Title
plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
Time Frame
up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
Title
oxygenation
Description
Changes in PaO2/FIO2 ratio
Time Frame
1 hour after extubation
Title
Chest-X ray
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20 Years and older
Patients undergoing thoracic surgery
Exclusion Criteria:
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
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