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

Sleep Disordered Breathing Clinical Trial

Official title:

Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082575
• Other study ID #: COV-MO-PO-A109
• Status: Completed
• Phase: N/A
• First received: March 5, 2010
• Last updated: August 5, 2014
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

No further details necessary or available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep Disordered Breathing

Intervention

Device:
• Oxygen Monitoring
No intervention

Locations

Country	Name	City	State
United States	Texas Health Research & Education Institute	Fort Worth	Texas
United States	Tulane University	New Orleans	Louisiana
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Adverse Events (AE) Caused by no Breathing	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	Five Nights	Yes