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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA050336-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitor only mode | Randomization will be to Oxalert in monitor-only mode |
| |
| Monitor in normal mode | Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxalert Monitor Mode | Device | The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators will enroll patients who are at increased risk for respiratory insufficiency. Specifically, the investigators will focus on patients scheduled for laparoscopic or open major abdominal or pelvic surgery whose analgesia is primarily opioid-based. The investigators will further restrict enrollment to obese patients (body mass index kg/m2) who are likely to have respiratory compromise. Both men and women will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36583643 | Derived | Li K, Saab R, Bravo M, Mascha EJ, Han Y, Nault R, Olson L, Sessler DI. Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial. Acta Anaesthesiol Scand. 2023 Apr;67(4):440-447. doi: 10.1111/aas.14193. Epub 2023 Jan 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Oxalert in Monitor in Normal Mode |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | number of participants analyzed for in hospital outcome and post-discharge outcome are different | Posted | Median | Inter-Quartile Range | % of SpO2 | during hospitalization up to 6 days and post-discharge 24 hours |
|
During hospitalization up to13 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild blisters on top of Arm after taking off the sticky patch after completing the monitoring part | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel I. Sessler, Professor & Chair | Cleveland Clinic | 216-445-6500 | DS@CCF.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2021 | Dec 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2021 | Aug 28, 2023 | ICF_001.pdf |
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| Oxalert Normal mode | Device | 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 | 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) |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ASA | Patients were categorized among the 4 ASA physical status according to the pre-anesthesia appointment. This classification uses a grading system of I (better) until IV (worse). ASA I: A normal healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
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 |
|
|
|
| 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. | number of participants analyzed for in hospital outcome and post-discharge outcome are different | Posted | Count of Participants | Participants | 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. | number of participants analyzed for in hospital outcome and post-discharge outcome are different | Posted | Median | Inter-Quartile Range | counts / minutes | 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%. | Posted | Mean | Inter-Quartile Range | % * min | 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. | Posted | Median | Inter-Quartile Range | counts | 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. | number of participants analyzed for in hospital outcome and post-discharge outcome are different | Posted | Median | Inter-Quartile Range | score on a scale | 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). | number of participants analyzed for in hospital outcome and post-discharge outcome are different | Posted | Median | Inter-Quartile Range | score on a scale | Post-operative day 1 (POD 1) |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 3 |
| 24 |
| EG001 | 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 | 0 | 25 | 0 | 25 | 2 | 25 |
The patient developed mild blisters on top of her Arm after she took off the sticky patch after completing the monitoring part. [MILD]
|
| monitor malfunction | Product Issues | Non-systematic Assessment | [MILD] |
|
| transferred to SICU On POD 1 1/20/2021 due to tachycardia | Cardiac disorders | Systematic Assessment | 010036 transferred to SICU On POD1 1/20/2021 due to tachycardia. IN SICU had a new onset of Atrial fibrillation, , stayed through the last observed day (POD6). [MODERATE] |
|
| had 2 episodes of successive tactile and verbal stimulation that caused extreme discomfort | Product Issues | Non-systematic Assessment | she is convinced that the problem is from the device since she was awake. The first time this happened was in hospital and the second time this happened was at home the night after discharge. [MILD] |
|
| Transfer form ward to SICU because of surgical reason | Surgical and medical procedures | Systematic Assessment | [MODERATE] |
|
| transferred to SICU On POD 1 1/20/2021 due to shortness of breath and desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 010036 transferred to SICU On POD1 1/20/2021 due to shortness of breath and desaturation. IN SICU had a new onset of Atrial fibrillation, stayed through the last observed day (POD6). |
|
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| Post-discharge any event |
|
|
| >0.99 |
| Risk Ratio (RR) |
| 1.0 |
| 2-Sided |
| 95 |
| 0.35 |
| 2.90 |
| Superiority |
| In hospital Duration> 2 min |
|
|
| In hospital Mean duration-all patients |
|
|
| In hospital Mean duration for events in those with any events |
|
|
| Post-discharge Duration |
|
|
variable: In hospital Total duration (min) |
| Wilcoxon (Mann-Whitney) |
| 0.133 |
| Median Difference (Final Values) |
| -46.1 |
| 2-Sided |
| 95 |
| -274 |
| 5.1 |
| Superiority |
Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test. |
| variable: In hospital Duration >2 min (min) | Wilcoxon (Mann-Whitney) | 0.075 | Median Difference (Final Values) | -24.1 | 2-Sided | 95 | -213 | 0.1 | Superiority |
| variable: In hospital Mean duration-all patients (min) | Wilcoxon (Mann-Whitney) | 0.009 | Median Difference (Final Values) | -2 | 2-Sided | 95 | -4.5 | -0.4 | Superiority |
| variable: in hospital mean duration for events in those with any events (min) | Wilcoxon (Mann-Whitney) | 0.001 | Median Difference (Final Values) | -2.2 | 2-Sided | 95 | -4.7 | -0.7 | Superiority |
| variable: post-discharge number | Wilcoxon (Mann-Whitney) | 0.584 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -4.0 | 1.0 | Superiority |
| variable: Post-discharge duration (min) | Wilcoxon (Mann-Whitney) | 0.556 | Median Difference (Final Values) | -1.3 | 2-Sided | 95 | -18.6 | 3.3 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test. |
| Degree of disturbing sleep (at the day of discharge) |
|
|
| Comfortable to wear (at the day of discharge) |
|
|
| Tolerable to audible alert (At the day of discharge) |
|
|
| Tolerable to tactile alert (at the day of discharge) |
|
|
| Easily cleaned/ disinfected (at the day of discharge) |
|
|
| Adequate battery life (at the day of discharge) |
|
|
| Satisfy with the electrode patch (at the day of discharge) |
|
|
| Willing to use after study (at the day of discharge) |
|
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| Disturb IV line (at the day of discharge) |
|
|
| Degree of disturbing daily life except sleep (after 24 hours of discharge) |
|
|
| Degree of disturbing sleep (after 24 hours of discharge) |
|
|
| Comfortable to wear (after 24 hours of discharge) |
|
|
| Tolerable to audible alert (after 24 hours of discharge) |
|
|
| Tolerable to tactile alert (after 24 hours of discharge) |
|
|
| Easily cleaned/ disinfected (after 24 hours of discharge) |
|
|
| Adequate battery life (after 24 hours of discharge) |
|
|
| Satisfy with the electrode patch (after 24 hours of discharge) |
|
|
| Willing to use after study (after 24 hours of discharge) |
|
|
| Disturb intravenous (IV) line (after 24 hours of discharge) |
|
variable: Degree of disturbing sleep (at the day of discharge) |
| Wilcoxon (Mann-Whitney) |
| 0.205 |
| Median Difference (Final Values) |
| 0.0 |
| 2-Sided |
| 95 |
| 0.0 |
| 2.0 |
| Superiority |
Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: comfortable to wear (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.839 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Tolerable to audible alert (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.621 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Tolerable to tactile alert | Wilcoxon (Mann-Whitney) | 0.898 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: easily cleaned/disinfected (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.654 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: adequate battery life (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.929 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Satisfy with the electrode patch (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.200 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Willing to use after study (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.987 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Disturb IV line (at the day of discharge) | Wilcoxon (Mann-Whitney) | 0.581 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Degree of disturbing daily life except sleep (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.180 | Median Difference (Final Values) | 1.0 | 2-Sided | 95 | 0.0 | 3.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: degree of distributing sleep (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.171 | Median Difference (Final Values) | 1.0 | 2-Sided | 95 | 0.0 | 2.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Tolerable to audible alert (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.074 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Tolerable to tactile alert (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.414 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -2.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Easily cleaned/disinfected (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.506 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Adequate battery life (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.747 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: satisfy with the electrode patch (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.023 | Median Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| variable: Willing to use after study (after 24 hours of discharge) | Wilcoxon (Mann-Whitney) | 0.023 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test |
| Easily cleaned/ disinfected |
|
|
| Adequate battery life |
|
|
| Satisfy with the electrode patch |
|
|
| Tolerable to audible alert |
|
|
| Willing to use after study |
|
|
| Patients' complaint about the device |
|
|
| Disturb IV line |
|
|
Easily cleaned/disinfected |
| Wilcoxon (Mann-Whitney) |
| 0.097 |
| Median Difference (Final Values) |
| 0.0 |
| 2-Sided |
| 95 |
| 0.0 |
| 1.0 |
| Superiority |
Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |
| variable: Adequate battery life | Wilcoxon (Mann-Whitney) | 0.02 | Median Difference (Final Values) | 1.0 | 2-Sided | 95 | 0.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |
| variable: Satisfy with the electrode patch | Wilcoxon (Mann-Whitney) | 0.037 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |
| variable: Tolerable to audible alert | Wilcoxon (Mann-Whitney) | 0.482 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -2.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |
| variable: Willing to use after study | Wilcoxon (Mann-Whitney) | 0.031 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |
| variable: Patients' complaint about the device | Wilcoxon (Mann-Whitney) | 0.947 | variable: Patients' complaint about the device | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 1.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |
| variable: Disturb IV line | Wilcoxon (Mann-Whitney) | 0.324 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | 0.0 | 0.0 | Superiority | Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test. |