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Oxygen Saturation Monitoring During Surgery

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: NCT01098851
Recruitment Status : Completed
First Posted : April 5, 2010
Results First Posted : June 29, 2011
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 Sleep Apnea, Obstructive
Enrollment 21
Recruitment Details Patients were recruited from July through November 2009 in the medical clinic who were scheduled for surgery that required procedural sedation.
Pre-assignment Details  
Arm/Group Title Obstructive Sleep Apnea Surgery Patients
Hide Arm/Group Description Surgery patients at high risk for Obstructive Sleep Apnea Surgery patients at low risk for Obstructive Sleep Apnea
Period Title: Overall Study
Started 11 10
Completed 10 10
Not Completed 1 0
Reason Not Completed
Equipment failure             1             0
Arm/Group Title Obstructive Sleep Apnea Surgery Patients Total
Hide Arm/Group Description Surgery patients at high risk for Obstructive Sleep Apnea Surgery patients at low risk for Obstructive Sleep Apnea Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  90.9%
10
 100.0%
20
  95.2%
>=65 years
1
   9.1%
0
   0.0%
1
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
59  (10) 36  (7) 48  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
5
  45.5%
10
 100.0%
15
  71.4%
Male
6
  54.5%
0
   0.0%
6
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow
Hide Description Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.
Time Frame 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Obstructive Sleep Apnea Surgery Patients
Hide Arm/Group Description:
Surgery patients at high risk for Obstructive Sleep Apnea
Surgery patients at low risk for Obstructive Sleep Apnea
Overall Number of Participants Analyzed 11 10
Measure Type: Number
Unit of Measure: Participants
4 0
2.Primary Outcome
Title Number of Participants Requiring Airway Support
Hide Description Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.
Time Frame 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Obstructive Sleep Apnea Surgery Patients
Hide Arm/Group Description:
Surgery patients at high risk for Obstructive Sleep Apnea
Surgery patients at low risk for Obstructive Sleep Apnea
Overall Number of Participants Analyzed 11 10
Measure Type: Number
Unit of Measure: Participants
8 4
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Obstructive Sleep Apnea Surgery Patients
Hide Arm/Group Description Surgery patients at high risk for Obstructive Sleep Apnea Surgery patients at low risk for Obstructive Sleep Apnea
All-Cause Mortality
Obstructive Sleep Apnea Surgery Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Obstructive Sleep Apnea Surgery Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Obstructive Sleep Apnea Surgery Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (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
Organization: Covidien
Phone: 303 305-2314
EMail: fran.haury@covidien.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01098851    
Other Study ID Numbers: COV-MO-PO-1000
First Submitted: March 31, 2010
First Posted: April 5, 2010
Results First Submitted: December 16, 2010
Results First Posted: June 29, 2011
Last Update Posted: August 7, 2014