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

NCT01082575 | Completed Results

• 1 other identifier: COV-MO-PO-A109
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Sleep Disordered Breathing

Keywords

Post Op Patients; Continuous Pulse Oximetry Monitoring; Major Surgery

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 days

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AE) Caused by no Breathing

  Five Nights

Study Arms (1)

Major Surgery

Oxygen Monitoring

Device: Oxygen Monitoring

Interventions

Oxygen Monitoring DEVICE

No intervention

Also known as: Nellcor Pulse Oximeter, N600X

Major Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital Patients

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Tulane University

New Orleans, Louisiana, 70131, United States

Location

Texas Health Research & Education Institute

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Fran Haury Clinical Program Manager II
• Organization: Covidien

fran.haury@covidien.com

303 305-2314

Study Officials

• Roger Mecca, MD

  Medtronic - MITG

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 7, 2014
• Results First Posted: October 4, 2012

Record last verified: 2014-08

Locations

US (3)