ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor

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: NCT01082575
Recruitment Status : Completed
First Posted : March 8, 2010
Results First Posted : October 4, 2012
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Sleep Disordered Breathing
Intervention Device: Oxygen Monitoring
Enrollment 100
Recruitment Details Patients were recruited from February 12, 2010 to June 25, 2010 from an acute care hospital.
Pre-assignment Details All enrolled patients were included into the trial. This was an observational study.
Arm/Group Title Major Surgery
Hide Arm/Group Description Post Operative patients
Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title Major Surgery
Hide Arm/Group Description Post Operative patients
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
55
  55.0%
>=65 years
45
  45.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
63.79  (12.018)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
54
  54.0%
Male
46
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
1.Primary Outcome
Title Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.
Hide Description Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.
Time Frame 5 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
93 evaluable patients out of 100 enrolled.
Arm/Group Title General Care Floor
Hide Arm/Group Description:
Observational General Care Floor Group
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: participants
74
2.Secondary Outcome
Title Number of Participants With Adverse Events (AE) Caused by no Breathing
Hide Description Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing
Time Frame Five Nights
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title General Care Floor
Hide Arm/Group Description:
Observational General Care Floor Group
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
0
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Major Surgery
Hide Arm/Group Description Post Operative patients
All-Cause Mortality
Major Surgery
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Major Surgery
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Major Surgery
Affected / at Risk (%)
Total   0/100 (0.00%) 
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: Fran Haury Clinical Program Manager II
Organization: Covidien
Phone: 303 305-2314
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01082575     History of Changes
Other Study ID Numbers: COV-MO-PO-A109
First Submitted: March 5, 2010
First Posted: March 8, 2010
Results First Submitted: February 8, 2012
Results First Posted: October 4, 2012
Last Update Posted: August 7, 2014