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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01630395
Other study ID # JHBahk_recruitment maneuver
Secondary ID
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


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
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