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

Completed

• Conditions: Sleep Disordered Breathing
• Interventions: Device: Oxygen Monitoring

• Registration Number: NCT01082575
• Lead Sponsor: 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.

Detailed Description

No further details necessary or available.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Results First Submitted: 2012-02-08
• Results First Submitted QC: 2012-09-04
• Results First Posted: 2012-10-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major Surgery	Oxygen Monitoring	Oxygen Monitoring

Primary Outcome Measures

Name	Time	Method
Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.	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

Name	Time	Method
Number of Participants With Adverse Events (AE) Caused by no Breathing	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

Trial Locations

Locations (3)

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States

Texas Health Research & Education Institute; 🇺🇸 Fort Worth, Texas, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States