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The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630395
First Posted: June 28, 2012
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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 ]
  • 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 ]
  • oxygenation [ Time Frame: 1 hour after extubation ]
    Changes in PaO2/FIO2 ratio

  • Chest-X ray [ Time Frame: 7 days after surgery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 21, 2012
First Posted: June 28, 2012
Last Update Posted: April 21, 2016
Last Verified: June 2012

Additional relevant MeSH terms:
Inflammation
Pathologic Processes