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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03174743
Other study ID # XYFY-2017-033
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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