NCT03128827

Brief Summary

The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

3.5 years

First QC Date

April 14, 2017

Last Update Submit

October 17, 2018

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Accuracy of RAM sensor to detect respiration rate

    Accuracy will be determined by comparing the noninvasive respiratory rate measurement of the sensor to that obtained from a reference and calculating the arithmetic root mean square (Arms) error value.

    1-6 hours

Study Arms (1)

Test Subjects

EXPERIMENTAL

All test subjects were pediatric patients following general anesthesia who received the RAM sensor which measures respiration rate.

Device: RAM sensor

Interventions

RAM sensorDEVICE

Acoustic Respiration Monitor

Test Subjects

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years old inclusive, male and female patients
  • Only patients with written informed consent signed by parents or legal guardians will be enrolled
  • In children 10 and older, patient's assent will be obtained

You may not qualify if:

  • Patients who are unable to give their consent and/or assent
  • Patients with skin abnormalities (rash, eczema, etc) at the planned application sites that would interfere with sensor, cannula or electrode applications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 25, 2017

Study Start

August 4, 2011

Primary Completion

January 20, 2015

Study Completion

July 24, 2015

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)