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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01082575
First received: March 5, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Sleep Disordered Breathing
Device: Oxygen Monitoring

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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:
  • Number of Participants With Adverse Events (AE) Caused by no Breathing [ Time Frame: Five Nights ] [ Designated as safety issue: Yes ]
    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


Enrollment: 100
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Major Surgery
Oxygen Monitoring
Device: Oxygen Monitoring
No intervention
Other Names:
  • Nellcor Pulse Oximeter
  • N600X

Detailed Description:

No further details necessary or available.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital Patients

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082575

Locations
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
Covidien
Investigators
Study Chair: Roger Mecca, MD Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01082575     History of Changes
Other Study ID Numbers: COV-MO-PO-A109
Study First Received: March 5, 2010
Results First Received: February 8, 2012
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
Post Op Patients
Continuous Pulse Oximetry Monitoring
Major Surgery

ClinicalTrials.gov processed this record on November 25, 2014