Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00715741
First received: July 10, 2008
Last updated: February 2, 2010
Last verified: February 2010
Results First Received: August 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Atelectasis
Interventions: Other: FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water
Other: FiO2 0.3 without PEEP
Other: FiO2 >0.9 with 3-5 cm water PEEP
Other: FiO2 >0.9 without PEEP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started 06/24/2008 and ended 07/07/2009. Subjects were recruited via the Operating room schedule

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP 30% oxygen with positive end expiratory pressure (PEEP)
Fi02 0.3 Without PEEP 30% oxygen without PEEP
Fi02 0.9 With PEEP 90% oxygen plus PEEP
Fi02 0.9 Without PEEP 90% oxygen without PEEP

Participant Flow:   Overall Study
    Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP     Fi02 0.3 Without PEEP     Fi02 0.9 With PEEP     Fi02 0.9 Without PEEP  
STARTED     25     25     25     25  
COMPLETED     25     25     25     25  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP 30% oxygen with positive end expiratory pressure (PEEP)
Fi02 0.3 Without PEEP 30% oxygen without PEEP
Fi02 0.9 With PEEP 90% oxygen plus PEEP
Fi02 0.9 Without PEEP 90% oxygen without PEEP
Total Total of all reporting groups

Baseline Measures
    Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP     Fi02 0.3 Without PEEP     Fi02 0.9 With PEEP     Fi02 0.9 Without PEEP     Total  
Number of Participants  
[units: participants]
  25     25     25     25     100  
Age, Customized  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     23     24     24     23     94  
>=65 years     2     1     1     2     6  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 13     45  ± 12     46  ± 15     46  ± 13     46  ± 13  
Gender  
[units: participants]
         
Female     13     15     12     15     55  
Male     12     10     13     10     45  
Region of Enrollment  
[units: participants]
         
United States     25     25     25     25     100  



  Outcome Measures
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1.  Primary:   Oxygen Requirement to Maintain SpO2>90%   [ Time Frame: 45 min after emergence (tracheal extubation) ]

2.  Primary:   Oxygen Requirement   [ Time Frame: 24 hours after tracheal extubation ]

3.  Secondary:   Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"   [ Time Frame: 45 min after tracheal extubation ]

4.  Secondary:   SpO2 Postoperatively   [ Time Frame: 24 hours after tracheal extubation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This data for this outcome measure is identical


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Harriet Hopf, MD
Organization: University of Utah
phone: 801-205-1013
e-mail: Harriet.Hopf@hsc.utah.edu


Publications:

Responsible Party: Harriet W. Hopf, M.D., Professor, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00715741     History of Changes
Other Study ID Numbers: 29830
Study First Received: July 10, 2008
Results First Received: August 11, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board