Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-06-02
2018-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Convential 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 of 60%.
Convential Ventilation 1
High tidal volume, moderate inspired oygen fraction (FiO2).
Convential Ventilation 2
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%.
Convential Ventilation 2
High tidal volume, high inspired oygen fraction (FiO2).
Protective ventilation 1
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.
Protective Ventilation 1
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
Protective ventilation 2
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.
Protective Ventilation 2
Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.
Interventions
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Convential Ventilation 1
High tidal volume, moderate inspired oygen fraction (FiO2).
Convential Ventilation 2
High tidal volume, high inspired oygen fraction (FiO2).
Protective Ventilation 1
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
Protective Ventilation 2
Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Pulmonary hypertension
3. Forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values
4. Coagulation disorder
5. Pulmonary or extrapulmonary infections
6. History of treatment with steroid in 3 months before surgery
7. History of recurrent pneumothorax
8. History of lung resection surgery
20 Years
75 Years
ALL
No
Sponsors
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Xuzhou Medical University
OTHER
Responsible Party
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Su Liu
Principal Investigator
Principal Investigators
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Liu Su Liu, M.D/Ph.D
Role: PRINCIPAL_INVESTIGATOR
徐州医科大学附属医院医学
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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XYFY-2017-033
Identifier Type: -
Identifier Source: org_study_id
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