Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT04453722
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
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Notify Me18 year–85 year
All sexes
Observational
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only 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
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.
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.
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.
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%.
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.
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.
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).
The Cleveland Clinic
Other
Wearable Device for Prevention of Opioid-Induced Hypoxemia
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.
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