Non-cardiac Surgery
Conditions
Brief summary
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
Detailed 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.
Interventions
DEVICEOxalert Monitor Mode
The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
DEVICEOxalert Normal 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
Sponsors
National Institute on Drug Abuse (NIDA)
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min | 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. |
| AUC of SpO2 Below a Threshold of 90% | during hospitalization up to 6 days and post-discharge 24 hours | AUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%. |
| Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | 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-weighted Average of SpO2 Below a Threshold of 90% | 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. |
| Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nurses' Attitude Toward the Device | 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). |
| Patients' Attitude Toward the Device | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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 | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Oxalert in Monitor in Normal Mode | Oxalert in Monitor Only Mode | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 16 | 57 years STANDARD_DEVIATION 12 | 55 years STANDARD_DEVIATION 14 |
| ASA mild systemic disease (2) | 2 Participants | 6 Participants | 8 Participants |
| ASA severe systemic disease (3) | 21 Participants | 16 Participants | 37 Participants |
| ASA severe systemic disease that is a constant threat to life (4) | 2 Participants | 2 Participants | 4 Participants |
| Body mass index | 30 kg/m^2 | 32 kg/m^2 | 31 kg/m^2 |
| Height | 168 cm STANDARD_DEVIATION 8 | 170 cm STANDARD_DEVIATION 10 | 169 cm STANDARD_DEVIATION 9 |
| Race/Ethnicity, Customized Race Black | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Female | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
| Surgery type Laparoscopy | 10 Participants | 6 Participants | 16 Participants |
| Surgery type Open | 15 Participants | 18 Participants | 33 Participants |
| Weight | 92 kg STANDARD_DEVIATION 16 | 94 kg STANDARD_DEVIATION 19 | 93 kg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 3 / 24 | 2 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
AUC of SpO2 Below a Threshold of 90%
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | AUC of SpO2 Below a Threshold of 90% | In hospital AUC | 1260 % * min |
| Oxalert in Monitor Only Mode | AUC of SpO2 Below a Threshold of 90% | Post-discharge AUC | 130 % * min |
| Oxalert in Monitor in Normal Mode | AUC of SpO2 Below a Threshold of 90% | In hospital AUC | 635 % * min |
| Oxalert in Monitor in Normal Mode | AUC of SpO2 Below a Threshold of 90% | Post-discharge AUC | 121 % * min |
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.
Time frame: during hospitalization up to 6 days and post-discharge 24 hours
Population: number of participants analyzed for in hospital outcome and post-discharge outcome are different
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Duration> 2 min | 34 counts / minutes |
| Oxalert in Monitor Only Mode | 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 |
| Oxalert in Monitor Only Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Mean duration-all patients | 4.7 counts / minutes |
| Oxalert in Monitor Only Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Post-discharge Duration | 5 counts / minutes |
| Oxalert in Monitor Only Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Total duration | 76 counts / minutes |
| Oxalert in Monitor in Normal Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Post-discharge Duration | 6 counts / minutes |
| Oxalert in Monitor in Normal Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Total duration | 30 counts / minutes |
| Oxalert in Monitor in Normal Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Duration> 2 min | 8 counts / minutes |
| Oxalert in Monitor in Normal Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Mean duration-all patients | 2.7 counts / minutes |
| Oxalert in Monitor in Normal Mode | Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Mean duration for events in those with any events | 2.7 counts / minutes |
Comparison: variable: In hospital Numberp-value: 0.35495% CI: [-26, 4]Wilcoxon (Mann-Whitney)
Comparison: variable: In hospital Total duration (min)p-value: 0.13395% CI: [-274, 5.1]Wilcoxon (Mann-Whitney)
Comparison: variable: In hospital Duration \>2 min (min)p-value: 0.07595% CI: [-213, 0.1]Wilcoxon (Mann-Whitney)
Comparison: variable: In hospital Mean duration-all patients (min)p-value: 0.00995% CI: [-4.5, -0.4]Wilcoxon (Mann-Whitney)
Comparison: variable: in hospital mean duration for events in those with any events (min)p-value: 0.00195% CI: [-4.7, -0.7]Wilcoxon (Mann-Whitney)
Comparison: variable: post-discharge numberp-value: 0.58495% CI: [-4, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Post-discharge duration (min)p-value: 0.55695% CI: [-18.6, 3.3]Wilcoxon (Mann-Whitney)
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.
Time frame: during hospitalization up to 6 days and post-discharge 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Number | 21 counts |
| Oxalert in Monitor Only Mode | Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Post Discharge Number | 2 counts |
| Oxalert in Monitor in Normal Mode | Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital Number | 12 counts |
| Oxalert in Monitor in Normal Mode | Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Post Discharge Number | 2 counts |
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.
Time frame: during hospitalization up to 6 days and post-discharge 24 hours
Population: number of participants analyzed for in hospital outcome and post-discharge outcome are different
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Post-discharge any event | 14 Participants |
| Oxalert in Monitor Only Mode | Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital any event | 20 Participants |
| Oxalert in Monitor in Normal Mode | Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min | In hospital any event | 21 Participants |
| Oxalert in Monitor in Normal Mode | Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min | Post-discharge any event | 14 Participants |
Comparison: variable: In hospital Any event, N (%)cp-value: >0.9995% CI: [0.22, 4.27]Fisher Exact
Comparison: variable: Post-discharge Any event, N (%)p-value: >0.9995% CI: [0.35, 2.9]Chi-squared
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.
Time frame: during hospitalization up to 6 days and post-discharge 24 hours
Population: number of participants analyzed for in hospital outcome and post-discharge outcome are different
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | Time-weighted Average of SpO2 Below a Threshold of 90% | In hospital TWA SpO2 <90% (%) | 0.29 % of SpO2 |
| Oxalert in Monitor Only Mode | Time-weighted Average of SpO2 Below a Threshold of 90% | Post-discharge TWA SpO2 <90% (%) | 0.16 % of SpO2 |
| Oxalert in Monitor in Normal Mode | Time-weighted Average of SpO2 Below a Threshold of 90% | In hospital TWA SpO2 <90% (%) | 0.11 % of SpO2 |
| Oxalert in Monitor in Normal Mode | Time-weighted Average of SpO2 Below a Threshold of 90% | Post-discharge TWA SpO2 <90% (%) | 0.10 % of SpO2 |
Comparison: variable: In hospital TWA SpO2 \<90% (%)p-value: 0.1295% CI: [-0.4, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: In hospital AUC SpO2 \<90% (% \* min)p-value: 0.34995% CI: [-1816, 208]Wilcoxon (Mann-Whitney)
Comparison: variable: Post-discharge TWA SpO2 \<90% (%)p-value: 0.30795% CI: [-0.2, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Post-discharge AUC SpO2 \<90% (% \* min)p-value: 0.43195% CI: [-195, 67]Wilcoxon (Mann-Whitney)
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).
Time frame: Post-operative day 1 (POD 1)
Population: number of participants analyzed for in hospital outcome and post-discharge outcome are different
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Degree of disturbing routine work | 1.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Easily cleaned/ disinfected | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Adequate battery life | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Satisfy with the electrode patch | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Tolerable to audible alert | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Willing to use after study | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Patients' complaint about the device | 2.0 score on a scale |
| Oxalert in Monitor Only Mode | Nurses' Attitude Toward the Device | Disturb IV line | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Disturb IV line | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Degree of disturbing routine work | 0.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Tolerable to audible alert | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Easily cleaned/ disinfected | 5.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Patients' complaint about the device | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Adequate battery life | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Willing to use after study | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Nurses' Attitude Toward the Device | Satisfy with the electrode patch | 4.0 score on a scale |
Comparison: Degree of disturbing routine workp-value: 0.7395% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: Easily cleaned/disinfectedp-value: 0.09795% CI: [0, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Adequate battery lifep-value: 0.0295% CI: [0, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Satisfy with the electrode patchp-value: 0.03795% CI: [0, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Tolerable to audible alertp-value: 0.48295% CI: [-2, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Willing to use after studyp-value: 0.03195% CI: [0, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Patients' complaint about the devicep-value: 0.94795% CI: [0, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Disturb IV linep-value: 0.32495% CI: [0, 0]Wilcoxon (Mann-Whitney)
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.
Time frame: At the day of discharge and after 24 hours of discharge
Population: number of participants analyzed for in hospital outcome and post-discharge outcome are different
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Easily cleaned/ disinfected (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Degree of disturbing daily life except sleep (after 24 hours of discharge) | 2.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Tolerable to audible alert (At the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Degree of disturbing sleep (after 24 hours of discharge) | 0.50 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Adequate battery life (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Comfortable to wear (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Comfortable to wear (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Tolerable to audible alert (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Satisfy with the electrode patch (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Tolerable to tactile alert (after 24 hours of discharge) | 2.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Tolerable to tactile alert (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Easily cleaned/ disinfected (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Willing to use after study (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Adequate battery life (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Degree of disturbing sleep (at the day of discharge) | 1.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Satisfy with the electrode patch (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Disturb IV line (at the day of discharge) | 2.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Willing to use after study (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor Only Mode | Patients' Attitude Toward the Device | Degree of disturbing daily life except sleep (at the day of discharge) | 1.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Willing to use after study (after 24 hours of discharge) | 3.5 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Degree of disturbing daily life except sleep (at the day of discharge) | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Degree of disturbing sleep (at the day of discharge) | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Comfortable to wear (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Tolerable to audible alert (At the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Tolerable to tactile alert (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Easily cleaned/ disinfected (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Adequate battery life (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Satisfy with the electrode patch (at the day of discharge) | 3.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Willing to use after study (at the day of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Disturb IV line (at the day of discharge) | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Degree of disturbing daily life except sleep (after 24 hours of discharge) | 3.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Degree of disturbing sleep (after 24 hours of discharge) | 2.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Comfortable to wear (after 24 hours of discharge) | 3.5 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Tolerable to audible alert (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Tolerable to tactile alert (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Easily cleaned/ disinfected (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Adequate battery life (after 24 hours of discharge) | 4.0 score on a scale |
| Oxalert in Monitor in Normal Mode | Patients' Attitude Toward the Device | Satisfy with the electrode patch (after 24 hours of discharge) | 2.5 score on a scale |
Comparison: variable: Degree of disturbing daily life except sleep (at the day of discharge)p-value: 0.09695% CI: [0, 2]Wilcoxon (Mann-Whitney)
Comparison: variable: Degree of disturbing sleep (at the day of discharge)p-value: 0.20595% CI: [0, 2]Wilcoxon (Mann-Whitney)
Comparison: variable: comfortable to wear (at the day of discharge)p-value: 0.83995% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Tolerable to audible alert (at the day of discharge)p-value: 0.62195% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Tolerable to tactile alertp-value: 0.89895% CI: [-1, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: easily cleaned/disinfected (at the day of discharge)p-value: 0.65495% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: adequate battery life (at the day of discharge)p-value: 0.92995% CI: [-1, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Satisfy with the electrode patch (at the day of discharge)p-value: 0.295% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Willing to use after study (at the day of discharge)p-value: 0.98795% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Disturb IV line (at the day of discharge)p-value: 0.58195% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Degree of disturbing daily life except sleep (after 24 hours of discharge)p-value: 0.1895% CI: [0, 3]Wilcoxon (Mann-Whitney)
Comparison: variable: degree of distributing sleep (after 24 hours of discharge)p-value: 0.17195% CI: [0, 2]Wilcoxon (Mann-Whitney)
Comparison: variable: Tolerable to audible alert (after 24 hours of discharge)p-value: 0.07495% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Tolerable to tactile alert (after 24 hours of discharge)p-value: 0.41495% CI: [-2, 1]Wilcoxon (Mann-Whitney)
Comparison: variable: Easily cleaned/disinfected (after 24 hours of discharge)p-value: 0.50695% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Adequate battery life (after 24 hours of discharge)p-value: 0.74795% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: satisfy with the electrode patch (after 24 hours of discharge)p-value: 0.02395% CI: [-2, 0]Wilcoxon (Mann-Whitney)
Comparison: variable: Willing to use after study (after 24 hours of discharge)p-value: 0.02395% CI: [-1, 0]Wilcoxon (Mann-Whitney)