Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes
ConditionApnea Infant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorWilliam Marsh Rice University
About this trial
A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BreathAlert, a low cost battery-powered monitor that detects and corrects apnea. This study evaluates the ability of BreathAlert to detect respiration and apneic episodes in infants. Data from BreathAlert and vital signs monitors is collected. The performance of BreathAlert in respiration and apnea detection is compared with traditional vital sign monitoring which may include temperature, heart rate, EKG, respiratory rate, SPO2 and impedance pneumography.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants will be identified using the eligibility criteria stipulated below.
The patient is currently being treated at QECH in the neonatal or pediatric ward.
The patient is deemed to be at risk for apnea or in need of respiratory rate monitoring.
A BreathAlert device is available for use while the patient is at risk for apnea.
Disqualifiers
None
Trial population
Patients in the neonatal or pediatric ward deemed to be at risk for apnea or in need of respiratory rate monitoring
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
BreathAlert (low cost respiratory rate and apnea monitor)
DeviceA BreathAlert device is attached to the subject. Data from BreathAlert and vital signs monitors is collected.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Patients in the neonatal/pediatric ward at risk for apnea or in need of respiratory rate monitoring1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of BreathAlert
Time frame
Maximum of one weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
William Marsh Rice University
Lead sponsor
Kamuzu University of Health Sciences
Collaborator
Source ClinicalTrials.gov