INVSENSOR00027 Clinical Performance Study

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: INVSENSOR00027

Study type: Interventional

Funder types: Industry

Identifiers

NCT03650192

TP-19415

Details and patient eligibility

About

This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 80 years old
• Physical status of ASA I or II
• Subjects must be able to read and communicate in English
• Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
• Has completed Health Assessment Questionnaire and passed health assessment screening

Exclusion criteria

• Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
• Inability to tolerate sitting still or minimal movement for at least 30 minutes
• Nursing female volunteers
• Excluded at the Principal Investigator's discretion
• Refusal to take the pregnancy test (for female subjects)
• Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
• Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

INVSENSOR00027 Test group

Experimental group

Description:

The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.

Treatment:

Device: INVSENSOR00027