Opioid Use
Conditions
Brief summary
This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Interventions
DEVICEMasimo SafetyNet Alert (MSNA)
This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Client Participants: * Participants who are18 years of age or greater * Participants housed within a supportive housing program who intend to inject opioids * Participants who have given verbal informed consent to participate in the study Inclusion Criteria for Staff Participants: * Participant is research staff and/or Rita Thompson Residence staff * Participant is willing to give implied consent by reading and completing the staff survey
Exclusion criteria
for Client Participants: * Participants deemed not suitable for the study at the discretion of the principal investigator, research staff or housing program nurses/staff * Participants with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, or other abnormalities that may interfere with MSNA functioning * Participants with known allergic reactions to foam/rubber products and/or adhesive tape
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | 2-4 weeks | Number of participants who demonstrated feasibility of MSNA in a supportive housing program |
Countries
Canada
Participant flow
Recruitment details
No staff participants were enrolled in this study prior to termination.
Participants by arm
| Arm | Count |
|---|---|
| Masimo SafetyNet Alert (MSNA) All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo SafetyNet Alert (MSNA)
Masimo SafetyNet Alert (MSNA): This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death: Unrelated to the device. The subject was enrolled but did not start any study activities | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Masimo SafetyNet Alert (MSNA) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Number of participants who demonstrated feasibility of MSNA in a supportive housing program
Time frame: 2-4 weeks
Population: 4 out of the 10 subjects were not completed due to physician decision, withdrawal by subject, or by death (unrelated to device, subject never participated in any study activities)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo SafetyNet Alert (MSNA) | Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | 6 participants |
Primary
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Summarizing proportion of incomplete studies to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program.
Time frame: 2-4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo SafetyNet Alert (MSNA) | Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | 4 incomplete studies |
Primary
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Summarizing proportion of lost components to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program.
Time frame: 2-4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo SafetyNet Alert (MSNA) | Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | 0 lost components |