The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

Inflammation Clinical Trial

Official title:

The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630395
• Other study ID #: JHBahk_recruitment maneuver
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: April 20, 2016
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 20 Years and older

• Patients undergoing thoracic surgery

Exclusion Criteria:

• Emergency surgery

• Heart failure

• Pulmonary hypertension

• Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values

• Coagulation disorder

• Pulmonary or extrapulmonary infections

• History of treatment with steroid in 3 months before surgery

• History of recurrent pneumothorax

• History of lung resection surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Mechanical Ventilation Complication
• Thoracic Surgery

Intervention

Procedure:
• protective ventilation
low tidal volume and PEEP
• Recruitment maneuver combined with protective ventilation
Low tidal volume, PEEP and recruitment maneuver

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of IL-8, TNFa in the bronchoalveolar lavage		up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery	No
Secondary	Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage		up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery	No
Secondary	plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa		up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery	No
Secondary	oxygenation	Changes in PaO2/FIO2 ratio	1 hour after extubation	No
Secondary	Chest-X ray		7 days after surgery	Yes