N/A
N=49
Prevention of Opioid-Induced Hypoxemia
Non-cardiac Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04453722 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Time-weighted Average of SpO2 Below a Threshold of 90% — 0.29; 0.11; 0.16; 0.10 % of SpO2 — p=0.120
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Oxalert Monitor Mode (Device); Oxalert Normal mode (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Average of SpO2 Below a Threshold of 90% |
0.29; 0.11; 0.16; 0.10 | 0.120 |
| PRIMARY Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min |
20; 21; 14; 14 | >0.99 |
| PRIMARY Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min |
76; 30; 34; 8; 4.7; 2.7 | 0.354 |
| PRIMARY AUC of SpO2 Below a Threshold of 90% |
1260; 635; 130; 121 | — |
| PRIMARY Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min |
21; 12; 2; 2 | — |
| SECONDARY Patients' Attitude Toward the Device |
1.0; 2.0; 1.0; 2.0; 4.0; 4.0 | 0.096 |
| SECONDARY Nurses' Attitude Toward the Device |
1.0; 0.0; 4.0; 5.0; 4.0; 4.0 | 0.73 |
Summary
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04453722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.