Clinical trial NCT03174743: Protective Ventilation During Pulmonary Lobectomy
Official title: The Effect of Protective Ventilation During Pulmonary Lobectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Complication
Thoracic Surgery
Inflammation
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1.20 Years and older 2.Patients undergoing pulmonary lobectomy

Exclusion Criteria:

1. Emergency surgery
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

Primary outcomes:
measure: The proportion of patients with pulmonary complication
timeFrame: up to postoperative 3days
Secondary outcomes:
measure: PaO2 /FiO2
timeFrame: 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
measure: respiratory compliance
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: IL6
timeFrame: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: IL10
timeFrame: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: 徐州医科大学附属医院医学
name: Liu Su Liu, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.