Skip to main content
OpenTrials
Completed

NCT Number: NCT04453722

Prevention of Opioid-Induced Hypoxemia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Oxalert Monitor Mode

Device

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

Oxalert Normal mode

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

Primary outcomes

  1. Time-weighted Average of SpO2 Below a Threshold of 90%

    Time frame: during hospitalization up to 6 days and post-discharge 24 hours

    Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation <90% is considered abnormal.

  2. Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min

    Time frame: during hospitalization up to 6 days and post-discharge 24 hours

    Number of Participants with Desaturation Events (Saturation <90%) Lasting at Least 2 Min. All the patients were included.

  3. Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min

    Time frame: during hospitalization up to 6 days and post-discharge 24 hours

    Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Mi. All desaturation events were included.

  4. AUC of SpO2 Below a Threshold of 90%

    Time frame: during hospitalization up to 6 days and post-discharge 24 hours

    AUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%.

  5. Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min

    Time frame: during hospitalization up to 6 days and post-discharge 24 hours

    Number of desaturation events (Saturation <90%) Lasting at Least 2 Mi. All desaturation events were included.

Secondary outcomes

  1. Patients' Attitude Toward the Device

    Time frame: At the day of discharge and after 24 hours of discharge

    We used 0-to-10 (Better - Worst) numerical rating scale to measure the degree of disturbing: 0 = "Not disturbed" and 10 = "Severely disturbed"; others are measured with 5-point numerical rating scales:1="Strongly disagree", 5="Strongly agree" (1=Better - 5= Worst). No subscales combining to compute a total score.

  2. Nurses' Attitude Toward the Device

    Time frame: Post-operative day 1 (POD 1)

    We used 0-to-10 (better- worst) numerical rating scale to measure the degree of disturbing: 0 = "Not disturbed" and 10 = "Severely disturbed"; others are measured with 5-point numerical rating scales:1="Strongly disagree", 5="Strongly agree" (1= better- 5=worst).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Wearable Device for Prevention of Opioid-Induced Hypoxemia

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 1, 2020
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.