Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
This study has been completed.
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01082575
First received: March 5, 2010
Last updated: September 4, 2012
Last verified: August 2012
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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: Pulse Oximeter |
| 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
Post Operative patients
|
Device: Pulse Oximeter
Continuous Pulse Oximetry
Other Name: Nellcor Pulse Oximeter
|
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
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
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: | September 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Covidien:
|
Post Op Patients Continuous Pulse Oximetry Monitoring Major Surgery |
Additional relevant MeSH terms:
|
Respiratory Aspiration Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013