Prevention of Opioid-Induced Hypoxemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-26

Study Completion Date

2023-06-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Non-cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Monitor only mode

Randomization will be to Oxalert in monitor-only mode

Oxalert Monitor Mode

Intervention Type DEVICE

The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.

Monitor in normal mode

Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.

Oxalert Normal mode

Intervention Type DEVICE

The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode

Interventions

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Oxalert Monitor Mode

The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.

Intervention Type DEVICE

Oxalert Normal mode

The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No