Prevention of Opioid-Induced Hypoxemia

NeuroTherapia, Inc.

Status

Completed

Conditions

Non-cardiac Surgery

Treatments

Device: Oxalert Normal mode

Device: Oxalert Monitor Mode

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04453722

1R43DA050336-01A1 (U.S. NIH Grant/Contract)

20-505

Details and patient eligibility

About

To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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).