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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082575
First Posted: March 8, 2010
Last Update Posted: August 7, 2014
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.
Information provided by (Responsible Party):
Medtronic - MITG
March 5, 2010
March 8, 2010
February 8, 2012
October 4, 2012
August 7, 2014
February 2010
July 2010   (Final data collection date for primary outcome measure)
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.
Prevalence of saturation patterns indicative of repetitive reductions in airflow [ Time Frame: Five Nights ]
Complete list of historical versions of study NCT01082575 on ClinicalTrials.gov Archive Site
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
Determine whether the occurrence of saturation patterns indicative of repetitive reductions in airflow is associated with post-operative adverse events [ Time Frame: Five Nights ]
Not Provided
Not Provided
 
Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow
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.
No further details necessary or available.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hospital Patients
Sleep Disordered Breathing
Device: Oxygen Monitoring
No intervention
Other Names:
  • Nellcor Pulse Oximeter
  • N600X
Major Surgery
Oxygen Monitoring
Intervention: Device: Oxygen Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01082575
COV-MO-PO-A109
No
Not Provided
Not Provided
Medtronic - MITG
Medtronic - MITG
Not Provided
Study Chair: Roger Mecca, MD Medtronic - MITG
Medtronic - MITG
August 2014