Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01078207
First received: February 26, 2010
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: May 14, 2012  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Obstructive Sleep Apnea

  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
From Feb 2010 to Oct 2010 adults at high risk for obstructive sleep apnea scheduled for general surgery requiring analgesia with an expected over night hospital stay were recruited from the hospital clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Adult Surgical Patients At Risk for Obstructive Sleep Apnea Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.

Participant Flow:   Overall Study
    Adult Surgical Patients At Risk for Obstructive Sleep Apnea  
STARTED     100  
COMPLETED     100  
NOT COMPLETED     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.
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Reporting Groups
  Description
Adult Surgical Patients At Risk for Obstructive Sleep Apnea Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.

Baseline Measures
    Adult Surgical Patients At Risk for Obstructive Sleep Apnea  
Number of Participants  
[units: participants]
  100  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     51  
>=65 years     49  
Age  
[units: years]
Mean ± Standard Deviation
  65.1  ± 9.2  
Gender  
[units: participants]
 
Female     22  
Male     78  
Region of Enrollment  
[units: participants]
 
Canada     100  



  Outcome Measures
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1.  Primary:   Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.   [ Time Frame: 12 hour after released from the recovery room ]

2.  Secondary:   Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.   [ Time Frame: 12 hours after discharge form the recovery room ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Fran Haury, RRT Research Coordinator, Clinical Affairs
Organization: Covidien
phone: 303 305-2314
e-mail: fran.haury@covidien.com


No publications provided


Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01078207     History of Changes
Other Study ID Numbers: COV-MO-PO-A105
Study First Received: February 26, 2010
Results First Received: May 14, 2012
Last Updated: August 5, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario