Clinical Trials Logo
  1. Home
  2. Respiration
  3. NCT01324817

Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates

Respiration Clinical Trial

Official title:
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates

Clinical Trial Summary

The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.

Clinical Trial Description

The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:

1. Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.

2. Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.

3. Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients. ;

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01324817
Study type Observational
Source Kai Medical, Inc.
Contact Venkataraman Balaraman, MD
Phone 808-983-6718
Email VBalaraman@kapiolani.org
Status Recruiting
Phase N/A
Start date January 2011
Completion date March 2012
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT00730119 - Evaluation Of The GE Monitor Product Line N/A
Not yet recruiting NCT05621642 - Telerehabilitation Based Exercise Training in Parkinson's Patients N/A
Recruiting NCT06354400 - Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children N/A
Completed NCT01176539 - Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor N/A
Recruiting NCT05302219 - Plethysmography Curve Variability Depending on the Breath Cycle N/A
Completed NCT03153345 - The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients N/A
Not yet recruiting NCT05886153 - Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (VERDICT-2) N/A
Completed NCT00827905 - Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check N/A
Completed NCT02946502 - Handgrip Strength Value in Predicting Mechanical Ventilation Weaning N/A
Completed NCT06247943 - Lung Protective Ventilation Strategies N/A
Completed NCT01694979 - Pelvic Floor Activity and Breathing in Women N/A
Withdrawn NCT01062789 - Optical Breath-hold Control System for Image-guided Procedures Phase 0
Completed NCT00893087 - Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care N/A
Completed NCT00730054 - Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers Phase 1/Phase 2
Completed NCT03119103 - Functional Bed Sheet Capturing Pressure Variation and Respiratory Effort Over Time N/A
Recruiting NCT03206528 - Clinical Evaluation of the Vital Signs Monitoring System (VSMS) N/A