Prevention of Opioid-Induced Hypoxemia

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.

Detailed Description
-----------------
The investigators will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. All patients will wear the Oxalert for 24 hours preoperatively in the monitoring only mode (no alerts), throughout hospitalization up to six days, and for 24 post-discharge hours. Randomization will be to Oxalert in monitor-only mode or to its normal mode which provides progressive audible and tactile alerts for hypoxemia.

Official Title
-----------------
Wearable Device for Prevention of Opioid-Induced Hypoxemia

Conditions
-----------------
Non-cardiac Surgery

Intervention / Treatment
-----------------
* Device: Oxalert Monitor
* Device: Oxalert Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults having major laparoscopic and open abdominal or pelvic surgeries; Body Mass Index ≥25 kg/m2 American Society of Anesthesiologists physical status 1-3; Age 18-85 years old; Able to understand and consent to the trial and fully participate; Anticipated primary opioid analgesia after surgery; Expected duration of hospitalization at least 24 hours after surgery; Consenting at least 24 hours before anticipated surgery. Exclusion Criteria: Epidural analgesia (field and fascial plane blocks permitted); Pre-operative SpO2 <95%; No wrist available for the study; Severe hearing loss; Lack of English language fluency. Serious hearing deficit (unable to understand normal speech in a quite environment) Serious peripheral neuropathy (unable to feel pin prick at wrist).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Oxalert in monitor only mode<br>Randomization will be to Oxalert in monitor-only mode | Device: Oxalert Monitor<br>* The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.<br>|
| Oxalert in monitor in normal mode<br>Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia. | Device: Oxalert Monitor<br>* The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fraction of time during the initial six post-operative in-hospital days that patients wear the device. |  | initial six post-op in hospital days. | 
| The frequency of hypoxemic episodes detected by the Oxalert EPO that generate an alert in the hospital. |  | 24 hours | 
| Time-weighted average SpO2 below a threshold of 90%. |  | 24 hours | 
| Duration of in-hospital postoperative desaturation events (saturation <90%) lasting at least 2 min. |  | 6 days | 
| Duration of hypoxemic episodes (saturation <90%) during the initial 24 post-discharge hours lasting at least 2 min. |  | 24 hours post discharge |