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

Study Overview
=================
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.

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

Conditions
-----------------
Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Device: Oxygen Monitoring


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major Surgery<br>Oxygen Monitoring | Device: Oxygen Monitoring<br>* No intervention<br>* Other names: N600X;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Op Patients, Continuous Pulse Oximetry Monitoring, Major Surgery