Non-cardiac Surgery Clinical Trial
Official title:
Wearable Device for Prevention of Opioid-Induced Hypoxemia
Verified date | February 2024 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
Status | Active, not recruiting |
Enrollment | 49 |
Est. completion date | December 30, 2024 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time-weighted Average of SpO2 Below a Threshold of 90% | Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation <90% is considered abnormal. | during hospitalization up to 6 days and post-discharge 24 hours | |
Primary | Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Number of Participants with Desaturation Events (Saturation <90%) Lasting at Least 2 Min. All the patients were included. | during hospitalization up to 6 days and post-discharge 24 hours | |
Primary | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Mi. All desaturation events were included. | during hospitalization up to 6 days and post-discharge 24 hours | |
Primary | AUC of SpO2 Below a Threshold of 90% | AUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%. | during hospitalization up to 6 days and post-discharge 24 hours | |
Primary | Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Number of desaturation events (Saturation <90%) Lasting at Least 2 Mi. All desaturation events were included. | during hospitalization up to 6 days and post-discharge 24 hours | |
Secondary | Patients' Attitude Toward the Device | 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. | At the day of discharge and after 24 hours of discharge | |
Secondary | Nurses' Attitude Toward the Device | 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). | Post-operative day 1 (POD 1) |
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