Back to resultsProtective Ventilation During Pulmonary Lobectomy
Primary Purpose
Pulmonary Complication, Thoracic Surgery, Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Convential Ventilation 1
Convential Ventilation 2
Protective Ventilation 1
Protective Ventilation 2
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Complication
Eligibility Criteria
Inclusion Criteria:
1.20 Years and older 2.Patients undergoing pulmonary lobectomy
Exclusion Criteria:
- Emergency surgery
- 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
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Convential Ventilation 1
Convential Ventilation 2
Protective ventilation 1
Protective ventilation 2
Arm Description
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 of 60%.
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%.
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers.
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers.
Outcomes
Primary Outcome Measures
The proportion of patients with pulmonary complication
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.
Secondary Outcome Measures
PaO2 /FiO2
respiratory compliance
Dynamic compliance, Static compliance
IL6
IL10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174743
Brief Title
Protective Ventilation During Pulmonary Lobectomy
Official Title
The Effect of Protective Ventilation During Pulmonary Lobectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.
Detailed Description
The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary 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
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Convential Ventilation 1
Arm Type
Placebo Comparator
Arm Description
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 of 60%.
Arm Title
Convential Ventilation 2
Arm Type
Placebo Comparator
Arm Description
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%.
Arm Title
Protective ventilation 1
Arm Type
Active Comparator
Arm Description
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers.
Arm Title
Protective ventilation 2
Arm Type
Active Comparator
Arm Description
Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers.
Intervention Type
Procedure
Intervention Name(s)
Convential Ventilation 1
Intervention Description
High tidal volume, moderate inspired oygen fraction (FiO2).
Intervention Type
Procedure
Intervention Name(s)
Convential Ventilation 2
Intervention Description
High tidal volume, high inspired oygen fraction (FiO2).
Intervention Type
Procedure
Intervention Name(s)
Protective Ventilation 1
Intervention Description
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
Intervention Type
Procedure
Intervention Name(s)
Protective Ventilation 2
Intervention Description
Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.
Primary Outcome Measure Information:
Title
The proportion of patients with pulmonary complication
Description
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.
Time Frame
up to postoperative 3days
Secondary Outcome Measure Information:
Title
PaO2 /FiO2
Time Frame
10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
Title
respiratory compliance
Description
Dynamic compliance, Static compliance
Time Frame
10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Title
IL6
Time Frame
10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Title
IL10
Time Frame
10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.20 Years and older 2.Patients undergoing pulmonary lobectomy
Exclusion Criteria:
Emergency surgery
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Su Liu, M.D/Ph.D
Phone
86-18118309692
Email
xyfymzk@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Su Liu, M.D/Ph.D
Organizational Affiliation
徐州医科大学附属医院医学
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Su Liu, MD/Ph.D
Phone
+86-18118309692
Email
xyfymzk@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available when this trial is finished and the article have been published.
Citations:
PubMed Identifier
19919624
Citation
Theroux MC, Fisher AO, Horner LM, Rodriguez ME, Costarino AT, Miller TL, Shaffer TH. Protective ventilation to reduce inflammatory injury from one lung ventilation in a piglet model. Paediatr Anaesth. 2010 Apr;20(4):356-64. doi: 10.1111/j.1460-9592.2009.03195.x. Epub 2009 Nov 16.
Results Reference
result
PubMed Identifier
23331507
Citation
Fuller BM, Mohr NM, Drewry AM, Carpenter CR. Lower tidal volume at initiation of mechanical ventilation may reduce progression to acute respiratory distress syndrome: a systematic review. Crit Care. 2013 Jan 18;17(1):R11. doi: 10.1186/cc11936.
Results Reference
result
PubMed Identifier
21436678
Citation
Kozian A, Schilling T, Schutze H, Senturk M, Hachenberg T, Hedenstierna G. Ventilatory protective strategies during thoracic surgery: effects of alveolar recruitment maneuver and low-tidal volume ventilation on lung density distribution. Anesthesiology. 2011 May;114(5):1025-35. doi: 10.1097/ALN.0b013e3182164356.
Results Reference
result
PubMed Identifier
19317902
Citation
Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24.
Results Reference
result
PubMed Identifier
22552387
Citation
Ishikawa S. Alveolar recruitment maneuver as an important part of protective one-lung ventilation. J Anesth. 2012 Oct;26(5):794-5. doi: 10.1007/s00540-012-1396-4. Epub 2012 May 3. No abstract available.
Results Reference
result
PubMed Identifier
20829341
Citation
Yang M, Ahn HJ, Kim K, Kim JA, Yi CA, Kim MJ, Kim HJ. Does a protective ventilation strategy reduce the risk of pulmonary complications after lung cancer surgery?: a randomized controlled trial. Chest. 2011 Mar;139(3):530-537. doi: 10.1378/chest.09-2293. Epub 2010 Sep 9.
Results Reference
result
PubMed Identifier
22349751
Citation
Kim SH, Jung KT, An TH. Effects of tidal volume and PEEP on arterial blood gases and pulmonary mechanics during one-lung ventilation. J Anesth. 2012 Aug;26(4):568-73. doi: 10.1007/s00540-012-1348-z. Epub 2012 Feb 18.
Results Reference
result
PubMed Identifier
22934859
Citation
Ahn HJ, Kim JA, Yang M, Shim WS, Park KJ, Lee JJ. Comparison between conventional and protective one-lung ventilation for ventilator-assisted thoracic surgery. Anaesth Intensive Care. 2012 Sep;40(5):780-8. doi: 10.1177/0310057X1204000505.
Results Reference
result
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Protective Ventilation During Pulmonary Lobectomy
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