TrialX
Image

Prevention of Opioid-Induced Hypoxemia

Prevention of Opioid-Induced Hypoxemia

Recruiting
18-85 years
All
Phase N/A

Overview

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

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.

Eligibility

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).

Study details
    Non-cardiac Surgery

NCT04453722

The Cleveland Clinic

5 August 2020

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.