MightySat - Clinical Performance Comparison Study

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: MightySat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03239574

TP-18810A

Details and patient eligibility

About

This study compares the performance of respiratory rate from pleth (RRp) measured with MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates ranging from 5 to 30 breaths per minute.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 45 years old
• Physical status of ASA I or II
• Must be able to read and communicate in English
• Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
• Passed health assessment screening
• Negative pregnancy test for female subjects of child bearing potential

Exclusion criteria

• Younger than 18 years old, older than 45 years old
• ASA physical status of III, IV, and V
• Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
• Inability to tolerate sitting still or minimal movement for at least 30 minutes
• Positive pregnancy test for female subjects
• Refusal to take pregnancy test for women of child bearing potential
• Nursing female subjects
• Refusal of male subjects to agree to shave hair off areas where sensors will be applied (neck)
• Excluded at Principal Investigator's discretion

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

MightySat Test group

Experimental group

Description:

The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.

Treatment:

Device: MightySat