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

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.
 
ClinicalTrials.gov Identifier: NCT01078207
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : August 1, 2012
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Obstructive Sleep Apnea
Enrollment 100
Recruitment Details 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  
Arm/Group Title Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
51
  51.0%
>=65 years
49
  49.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
65.1  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
22
  22.0%
Male
78
  78.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 100 participants
100
1.Primary Outcome
Title Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.
Hide Description Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects
Time Frame 12 hour after released from the recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with complete data were analyzed.
Arm/Group Title Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 83
Measure Type: Number
Unit of Measure: participants
30
2.Secondary Outcome
Title Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.
Hide Description The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.
Time Frame 12 hours after discharge form the recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with a positive repetitive reduction in nasal airflow.
Arm/Group Title Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
20
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Hide Arm/Group Description 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.
All-Cause Mortality
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Affected / at Risk (%)
Total   0/100 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Affected / at Risk (%)
Total   0/100 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fran Haury, RRT Research Coordinator, Clinical Affairs
Organization: Covidien
Phone: 303 305-2314
EMail: fran.haury@covidien.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01078207    
Other Study ID Numbers: COV-MO-PO-A105
First Submitted: February 26, 2010
First Posted: March 2, 2010
Results First Submitted: May 14, 2012
Results First Posted: August 1, 2012
Last Update Posted: August 7, 2014