RECRUITING

Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.

Official Title

Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

Quick Facts

Study Start:2023-12-21

Study Completion:2025-02-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06432881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is 18 years of age or older. * Subject is receiving care in an intensive care unit. * Subject with an arterial catheter in place. * Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air	* Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity). * Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.). * Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care. * Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied. * Subjects with known allergic reactions to adhesive tapes. * Subjects with arterial catheter placed in a lower extremity. * Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.

Inclusion Criteria

Exclusion Criteria

* Subject is 18 years of age or older.
* Subject is receiving care in an intensive care unit.
* Subject with an arterial catheter in place.
* Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air

* Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity).
* Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
* Subjects with known allergic reactions to adhesive tapes.
* Subjects with arterial catheter placed in a lower extremity.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.

Contacts and Locations

Study Contact

Chelsea Frank

CONTACT

949-297-7000

clinicalresearchdept@masimo.com

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Masimo Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21

Study Completion Date2025-02-21

Study Record Updates

Study Start Date2023-12-21

Study Completion Date2025-02-21

Terms related to this study

Additional Relevant MeSH Terms

Hypoxemia