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Protocol procedure did not adequately meet data needs for the study.
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This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00011 Test group | Experimental | The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00011 | Device | INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of INVSENSOR00011's Posture Change Detection | Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection) | Approximately 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Detection | When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences. | Approximately 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Clinical Lab | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | INVSENSOR00011 Test Group | The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00011 Test Group | The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: investigational sensor that will be placed on the subject's chest and/or back for the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sensitivity of INVSENSOR00011's Posture Change Detection | Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection) | The protocol required a minimum of 30 subjects to sufficiently evaluate a detection sensitivity for INVSENSOR00011 sensor's posture change detection algorithm. The study was not able to meet this enrollment target and enrolled only 10 subjects, therefore data should be interpreted with caution due to the insufficient sample size. Across 10 enrolled subjects, there were 100 posture and activity related transitions observed (these include right, left, supine, upright and walking events). | Posted | Number | percent aggregate detection sensitivity | Approximately 30 minutes | Posture and Activity Related Transitions | Posture and Activity Related Transitions |
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From the time of INVSENSOR00011 application until the sensor(s) is removed, approximately 30 minutes.
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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 | INVSENSOR00011 Test Group | The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo | 949-297-7000 | studies@masimo.com |
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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 | Dec 5, 2017 | Sep 13, 2021 | Prot_SAP_001.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study. |
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| Secondary | Respiratory Rate Detection | When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences. | The protocol required a minimum of 30 subjects to sufficiently evaluate accuracy of the RR parameter. The study was not able to meet this enrollment target, therefore data should be interpreted with caution due to the insufficient sample size. An error analysis was carried out with reference measurements to assess INVSENSOR00011's RR accuracy. Across 10 enrolled subjects, the RR values from the device was compared against the reference RR to compute mean and standard deviation of bias (SDE). | Posted | Mean | Standard Deviation | breaths per minute | Approximately 20 minutes |
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| 10 |
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| 10 |
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