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The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01630395
First received: June 21, 2012
Last updated: April 20, 2016
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 ]

Enrollment: 60
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: March 2014 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

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: April 20, 2016
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 27, 2016