Protective Ventilation During Pulmonary Lobectomy

Inflammation Clinical Trial

Official title:

The Effect of Protective Ventilation During Pulmonary Lobectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03174743
• Other study ID #: XYFY-2017-033
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2017
• Last updated: June 4, 2017
• Start date: June 2, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: June 2017
• Source: Xuzhou Medical University
• Contact: Liu Su Liu, M.D/Ph.D
• Phone: 86-18118309692
• Email: xyfymzk[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pulmonary Complication
• Thoracic Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. Review. — View 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. — View 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. — View Citation

Kozian A, Schilling T, Schütze 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. 2 — View 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. — View 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.1460-9592.2009.0 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	respiratory compliance	Dynamic compliance, Static compliance	10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Secondary	IL6		10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Secondary	IL10		10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation