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

Tracking Information
First Submitted Date	March 5, 2010
First Posted Date	March 8, 2010
Results First Submitted Date	February 8, 2012
Results First Posted Date	October 4, 2012
Last Update Posted Date	August 7, 2014
Study Start Date	February 2010
Actual Primary Completion Date	July 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 4, 2012)	Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. [ Time Frame: 5 days ]; 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.
Original Primary Outcome Measures; (submitted: March 5, 2010)	Prevalence of saturation patterns indicative of repetitive reductions in airflow [ Time Frame: Five Nights ]
Change History	Complete list of historical versions of study NCT01082575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 4, 2012)	Number of Participants With Adverse Events (AE) Caused by no Breathing [ Time Frame: Five Nights ]; 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
Original Secondary Outcome Measures; (submitted: March 5, 2010)	Determine whether the occurrence of saturation patterns indicative of repetitive reductions in airflow is associated with post-operative adverse events [ Time Frame: Five Nights ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
Official Title	Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow
Brief Summary	The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.
Detailed Description	No further details necessary or available.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Hospital Patients
Condition	Sleep Disordered Breathing
Intervention	Device: Oxygen Monitoring; No intervention; Other Names: Nellcor Pulse Oximeter; N600X
Study Groups/Cohorts	Major Surgery; Oxygen Monitoring; Intervention: Device: Oxygen Monitoring
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: March 5, 2010)	100
Original Estimated Enrollment	Same as current
Actual Study Completion Date	August 2010
Actual Primary Completion Date	July 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Age of 18 years or older; Discharge from the post-anesthesia care unit (PACU) to the GCF after any of the following major surgeries: bariatric surgery, major orthopedic surgery (e.g., total hip replacement), major general surgery (e.g., bowel resections, open cholecystectomy), and major gynecological surgery (e.g., radical hysterectomy) Exclusion Criteria: Pre-existing central neurological disease, including but not limited to recent traumatic brain injury, stroke, and neurodegenerative disease; Ongoing use of mechanical ventilation or continuous positive airway pressure in the GCF
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01082575
Other Study ID Numbers	COV-MO-PO-A109
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medtronic - MITG
Study Sponsor	Medtronic - MITG
Collaborators	Not Provided
Investigators	Study Chair: Roger Mecca, MD Medtronic - MITG
PRS Account	Medtronic - MITG
Verification Date	August 2014