Trial Outcomes & Findings for Prevention of Opioid-Induced Hypoxemia (NCT NCT04453722)
NCT ID: NCT04453722
Last Updated: 2025-08-29
Results Overview
Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation \<90% is considered abnormal.
Recruitment status
COMPLETED
Target enrollment
49 participants
Primary outcome timeframe
during hospitalization up to 6 days and post-discharge 24 hours
Results posted on
2025-08-29
Participant Flow
Participant milestones
| Measure |
Oxalert in Monitor Only Mode
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Opioid-Induced Hypoxemia
Baseline characteristics by cohort
| Measure |
Oxalert in Monitor Only Mode
n=24 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=25 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 12 • n=5 Participants
|
52 years
STANDARD_DEVIATION 16 • n=7 Participants
|
55 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ASA
mild systemic disease (2)
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
ASA
severe systemic disease (3)
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
ASA
severe systemic disease that is a constant threat to life (4)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Surgery type
Laparoscopy
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Surgery type
Open
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Height
|
170 cm
STANDARD_DEVIATION 10 • n=5 Participants
|
168 cm
STANDARD_DEVIATION 8 • n=7 Participants
|
169 cm
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Weight
|
94 kg
STANDARD_DEVIATION 19 • n=5 Participants
|
92 kg
STANDARD_DEVIATION 16 • n=7 Participants
|
93 kg
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Body mass index
|
32 kg/m^2
n=5 Participants
|
30 kg/m^2
n=7 Participants
|
31 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: during hospitalization up to 6 days and post-discharge 24 hoursPopulation: number of participants analyzed for in hospital outcome and post-discharge outcome are different
Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation \<90% is considered abnormal.
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=23 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=24 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: 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-weighted Average of SpO2 Below a Threshold of 90%
In hospital TWA SpO2 <90% (%)
|
0.29 % of SpO2
Interval 0.04 to 0.71
|
0.11 % of SpO2
Interval 0.03 to 0.25
|
|
Time-weighted Average of SpO2 Below a Threshold of 90%
Post-discharge TWA SpO2 <90% (%)
|
0.16 % of SpO2
Interval 0.04 to 0.81
|
0.10 % of SpO2
Interval 0.04 to 0.32
|
PRIMARY outcome
Timeframe: during hospitalization up to 6 days and post-discharge 24 hoursPopulation: number of participants analyzed for in hospital outcome and post-discharge outcome are different
Number of Participants with Desaturation Events (Saturation \<90%) Lasting at Least 2 Min. All the patients were included.
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=23 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=24 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min
In hospital any event
|
20 Participants
|
21 Participants
|
|
Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min
Post-discharge any event
|
14 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: during hospitalization up to 6 days and post-discharge 24 hoursPopulation: number of participants analyzed for in hospital outcome and post-discharge outcome are different
Duration of Desaturation Events (Saturation \<90%) Lasting at Least 2 Mi. All desaturation events were included.
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=23 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=24 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
In hospital Total duration
|
76 counts / minutes
Interval 3.0 to 531.0
|
30 counts / minutes
Interval 7.0 to 145.0
|
|
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
In hospital Duration> 2 min
|
34 counts / minutes
Interval 0.8 to 465.0
|
8 counts / minutes
Interval 2.0 to 63.0
|
|
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
In hospital Mean duration-all patients
|
4.7 counts / minutes
Interval 2.8 to 8.6
|
2.7 counts / minutes
Interval 2.3 to 3.6
|
|
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
In hospital Mean duration for events in those with any events
|
5.1 counts / minutes
Interval 3.5 to 8.7
|
2.7 counts / minutes
Interval 2.6 to 3.7
|
|
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
Post-discharge Duration
|
5 counts / minutes
Interval 0.0 to 70.0
|
6 counts / minutes
Interval 0.0 to 12.0
|
PRIMARY outcome
Timeframe: during hospitalization up to 6 days and post-discharge 24 hoursAUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%.
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=23 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=24 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
AUC of SpO2 Below a Threshold of 90%
In hospital AUC
|
1260 % * min
Interval 117.0 to 5278.0
|
635 % * min
Interval 204.0 to 1513.0
|
|
AUC of SpO2 Below a Threshold of 90%
Post-discharge AUC
|
130 % * min
Interval 47.0 to 1038.0
|
121 % * min
Interval 27.0 to 428.0
|
PRIMARY outcome
Timeframe: during hospitalization up to 6 days and post-discharge 24 hoursNumber of desaturation events (Saturation \<90%) Lasting at Least 2 Mi. All desaturation events were included.
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=23 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=24 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
In hospital Number
|
21 counts
Interval 1.0 to 69.0
|
12 counts
Interval 3.0 to 23.0
|
|
Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
Post Discharge Number
|
2 counts
Interval 0.0 to 13.0
|
2 counts
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: At the day of discharge and after 24 hours of dischargePopulation: number of participants analyzed for in hospital outcome and post-discharge outcome are different
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.
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=21 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=21 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Patients' Attitude Toward the Device
Willing to use after study (after 24 hours of discharge)
|
4.0 score on a scale
Interval 4.0 to 4.0
|
3.5 score on a scale
Interval 3.0 to 4.0
|
|
Patients' Attitude Toward the Device
Degree of disturbing daily life except sleep (after 24 hours of discharge)
|
2.0 score on a scale
Interval 0.0 to 3.0
|
3.0 score on a scale
Interval 0.5 to 5.0
|
|
Patients' Attitude Toward the Device
Degree of disturbing sleep (after 24 hours of discharge)
|
0.50 score on a scale
Interval 0.0 to 2.5
|
2.0 score on a scale
Interval 0.0 to 4.5
|
|
Patients' Attitude Toward the Device
Comfortable to wear (after 24 hours of discharge)
|
4.0 score on a scale
Interval 3.0 to 4.0
|
3.5 score on a scale
Interval 2.0 to 4.0
|
|
Patients' Attitude Toward the Device
Tolerable to audible alert (after 24 hours of discharge)
|
4.0 score on a scale
Interval 4.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 4.0
|
|
Patients' Attitude Toward the Device
Tolerable to tactile alert (after 24 hours of discharge)
|
2.0 score on a scale
Interval 2.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Patients' Attitude Toward the Device
Easily cleaned/ disinfected (after 24 hours of discharge)
|
4.0 score on a scale
Interval 4.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 4.0
|
|
Patients' Attitude Toward the Device
Adequate battery life (after 24 hours of discharge)
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Patients' Attitude Toward the Device
Satisfy with the electrode patch (after 24 hours of discharge)
|
4.0 score on a scale
Interval 3.5 to 4.0
|
2.5 score on a scale
Interval 2.0 to 4.0
|
|
Patients' Attitude Toward the Device
Adequate battery life (at the day of discharge)
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Patients' Attitude Toward the Device
Satisfy with the electrode patch (at the day of discharge)
|
4.0 score on a scale
Interval 3.0 to 4.0
|
3.0 score on a scale
Interval 2.0 to 4.0
|
|
Patients' Attitude Toward the Device
Willing to use after study (at the day of discharge)
|
4.0 score on a scale
Interval 4.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Patients' Attitude Toward the Device
Disturb IV line (at the day of discharge)
|
2.0 score on a scale
Interval 2.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 3.0
|
|
Patients' Attitude Toward the Device
Degree of disturbing daily life except sleep (at the day of discharge)
|
1.0 score on a scale
Interval 0.0 to 3.0
|
2.0 score on a scale
Interval 1.0 to 4.0
|
|
Patients' Attitude Toward the Device
Degree of disturbing sleep (at the day of discharge)
|
1.0 score on a scale
Interval 0.0 to 1.0
|
2.0 score on a scale
Interval 0.0 to 3.0
|
|
Patients' Attitude Toward the Device
Comfortable to wear (at the day of discharge)
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Patients' Attitude Toward the Device
Tolerable to audible alert (At the day of discharge)
|
4.0 score on a scale
Interval 4.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 4.0
|
|
Patients' Attitude Toward the Device
Tolerable to tactile alert (at the day of discharge)
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.5 to 4.0
|
|
Patients' Attitude Toward the Device
Easily cleaned/ disinfected (at the day of discharge)
|
4.0 score on a scale
Interval 4.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Post-operative day 1 (POD 1)Population: number of participants analyzed for in hospital outcome and post-discharge outcome are different
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).
Outcome measures
| Measure |
Oxalert in Monitor Only Mode
n=23 Participants
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=25 Participants
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Nurses' Attitude Toward the Device
Degree of disturbing routine work
|
1.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 2.0
|
|
Nurses' Attitude Toward the Device
Easily cleaned/ disinfected
|
4.0 score on a scale
Interval 4.0 to 5.0
|
5.0 score on a scale
Interval 4.0 to 5.0
|
|
Nurses' Attitude Toward the Device
Adequate battery life
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 5.0
|
|
Nurses' Attitude Toward the Device
Satisfy with the electrode patch
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 4.0
|
|
Nurses' Attitude Toward the Device
Tolerable to audible alert
|
4.0 score on a scale
Interval 3.5 to 4.5
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Nurses' Attitude Toward the Device
Willing to use after study
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 4.0 to 5.0
|
|
Nurses' Attitude Toward the Device
Patients' complaint about the device
|
2.0 score on a scale
Interval 1.0 to 2.0
|
2.0 score on a scale
Interval 1.0 to 2.0
|
|
Nurses' Attitude Toward the Device
Disturb IV line
|
2.0 score on a scale
Interval 2.0 to 2.0
|
2.0 score on a scale
Interval 1.0 to 2.0
|
Adverse Events
Oxalert in Monitor Only Mode
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Oxalert in Monitor in Normal Mode
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxalert in Monitor Only Mode
n=24 participants at risk
Randomization will be to Oxalert in monitor-only mode
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
|
Oxalert in Monitor in Normal Mode
n=25 participants at risk
Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
Oxalert Monitor: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
mild blisters on top of Arm after taking off the sticky patch after completing the monitoring part
|
4.2%
1/24 • During hospitalization up to13 days
|
0.00%
0/25 • During hospitalization up to13 days
|
|
Product Issues
monitor malfunction
|
4.2%
1/24 • During hospitalization up to13 days
|
0.00%
0/25 • During hospitalization up to13 days
|
|
Cardiac disorders
transferred to SICU On POD 1 1/20/2021 due to tachycardia
|
4.2%
1/24 • During hospitalization up to13 days
|
0.00%
0/25 • During hospitalization up to13 days
|
|
Product Issues
had 2 episodes of successive tactile and verbal stimulation that caused extreme discomfort
|
0.00%
0/24 • During hospitalization up to13 days
|
4.0%
1/25 • During hospitalization up to13 days
|
|
Surgical and medical procedures
Transfer form ward to SICU because of surgical reason
|
0.00%
0/24 • During hospitalization up to13 days
|
4.0%
1/25 • During hospitalization up to13 days
|
|
Respiratory, thoracic and mediastinal disorders
transferred to SICU On POD 1 1/20/2021 due to shortness of breath and desaturation
|
4.2%
1/24 • During hospitalization up to13 days
|
100.0%
1/1 • During hospitalization up to13 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place