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The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT01630395
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Thoracic Surgery Inflammation Procedure: protective ventilation Procedure: Recruitment maneuver combined with protective ventilation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. oxygenation [ Time Frame: 1 hour after extubation ]
    Changes in PaO2/FIO2 ratio

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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
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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
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01630395    
Other Study ID Numbers: JHBahk_recruitment maneuver
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: June 2012
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes