The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication; Thoracic Surgery; Inflammation
• Interventions: Procedure: Recruitment maneuver combined with protective ventilation; Procedure: protective ventilation

• Registration Number: NCT01630395
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 20 Years and older
• Patients undergoing thoracic surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recruitment	Recruitment maneuver combined with protective ventilation	Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation.
Protective	protective ventilation	Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
oxygenation	1 hour after extubation	Changes in PaO2/FIO2 ratio
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
Chest-X ray	7 days after surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of