The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

This study is currently recruiting participants.
Verified June 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01630395
First received: June 21, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Mechanical Ventilation Complication
Thoracic Surgery
Inflammation
Procedure: protective ventilation
Procedure: Recruitment maneuver combined with protective ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Levels of IL-8, TNFa in the bronchoalveolar lavage [ Time Frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage [ Time Frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery ] [ Designated as safety issue: No ]
  • plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa [ Time Frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery ] [ Designated as safety issue: No ]
  • oxygenation [ Time Frame: 1 hour after extubation ] [ Designated as safety issue: No ]
    Changes in PaO2/FIO2 ratio

  • Chest-X ray [ Time Frame: 7 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630395

Contacts
Contact: Jae-Hyon Bahk, MD, PhD 82-2-2072-2818 bahkjh@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae-Hyon Bahk, MD, PhD    82-2-2072-2818    bahkjh@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01630395     History of Changes
Other Study ID Numbers: JHBahk_recruitment maneuver
Study First Received: June 21, 2012
Last Updated: June 26, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014