The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Mechanical Ventilation Complication; Thoracic Surgery
• Intervention / Treatment: Procedure: protective ventilation; Procedure: Recruitment maneuver combined with protective ventilation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: conventional; Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP
Active Comparator: Protective; Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.	Procedure: protective ventilation; low tidal volume and PEEP
Active Comparator: Recruitment; 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.	Procedure: Recruitment maneuver combined with protective ventilation; Low tidal volume, PEEP and recruitment maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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	Changes in PaO2/FIO2 ratio	1 hour after extubation
Chest-X ray		7 days after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: JHBahk_recruitment maneuver