Dallas, Texas 75235

  • Respiration Rate

Purpose:

The objective of this clinical investigational study is to compare the acoustic respiration rates (RRa) obtained using the INVSENSOR0004 sensor in the subjects up to 10 kg with the respiration rates determined by manual annotations (RRref), and when applicable with capnography respiration rate (RRcap).


Criteria:

Inclusion Criteria: - Subjects weighing up to 10kg - Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit) - The parent/legal guardian has given written informed consent/assent to participate in the study. Exclusion Criteria: - Subjects with underdeveloped skin - Subjects 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 burns, scar tissue, infections, abnormalities, etc. - Subjects deemed not suitable for the study at the discretion of the investigator.


NCT ID:

NCT03482505


Primary Contact:

Vikram Ramakanth, DEng
Phone: 949-297-7416
Email: clinicalresearchdept@masimo.com


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75235
United States

Peter Szmuk, MD
Phone: 214-456-6404
Email: Peter.Szmuk@UTSouthwestern.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.