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The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convential Ventilation 1 | Placebo Comparator | 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 2 | Placebo Comparator | 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%. |
|
| Protective ventilation 1 | Active Comparator | 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 2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convential Ventilation 1 | Procedure | High tidal volume, moderate inspired oygen fraction (FiO2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to postoperative 3days |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2 /FiO2 | 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 | |
| respiratory compliance | Dynamic compliance, Static compliance |
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Inclusion Criteria:
1.20 Years and older 2.Patients undergoing pulmonary lobectomy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Su Liu, M.D/Ph.D | Contact | 86-18118309692 | xyfymzk@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Su Liu, M.D/Ph.D | 徐州医科大学附属医院医学 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19919624 | Result | 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. | |
| 23331507 | Result | 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. |
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IPD will be available when this trial is finished and the article have been published.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Convential Ventilation 2 | Procedure | High tidal volume, high inspired oygen fraction (FiO2). |
|
| Protective Ventilation 1 | Procedure | Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver. |
|
| Protective Ventilation 2 | Procedure | Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver. |
|
| 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation |
| IL6 | 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation |
| IL10 | 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation |
| 21436678 | Result | 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. |
| 19317902 | Result | 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. |
| 22552387 | Result | 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. |
| 20829341 | Result | 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. |
| 22349751 | Result | 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. |
| 22934859 | Result | 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. |