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

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.

Condition or disease Intervention/treatment
Sleep Disordered Breathing Device: Oxygen Monitoring

Detailed Description:
No further details necessary or available.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Major Surgery
Oxygen Monitoring
Device: Oxygen Monitoring
No intervention
Other Names:
  • Nellcor Pulse Oximeter
  • N600X

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital Patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082575

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United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70131
United States, Texas
Texas Health Research & Education Institute
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Medtronic - MITG
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Study Chair: Roger Mecca, MD Medtronic - MITG
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Responsible Party: Medtronic - MITG Identifier: NCT01082575    
Other Study ID Numbers: COV-MO-PO-A109
First Posted: March 8, 2010    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: August 7, 2014
Last Verified: August 2014
Keywords provided by Medtronic - MITG:
Post Op Patients
Continuous Pulse Oximetry Monitoring
Major Surgery
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases