- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04584814
Analyze Changes in Respiratory Rate When Using the Scare Respirator (RESPSUS)
Pilot Study of Using the Scare Respirator: Effect on Synchronicity, Respiratory Rate, Heart Rate, Oxygen Saturation, Neonatal-Infant Pain Scale (NIPS) and Sleep-wake Cycle on Amplitude Electroencephalography( aEEG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With this pilot study the investigator's want to see if the "scare respirator" can modify the vital signs of the newborn (NB) and if there is a relationship according to the frequency per minute given by the scare respirator and the patient's respiratory rate.
The "scare respirator" has been used many times to prevent central apnea in the newborn. This involves using a mechanical ventilator, but instead of connecting it to the patient's trachea to inflate his lungs, the air flow is connected to a surgical glove that inflates and deflates, with the optimal respiratory rate that the patient should have. This will be placed on the back to stimulate it tactically giving the necessary impulse of inspiration so that the patient alone can acquire the movement.
The importance of the development of this study is that it has been seen that the "scare respirator" could avoid central apneas, but no studies have been done on the change in respiratory rate that occurs with the device or if it bothers the NB or alters its wakefulness sleep pattern.
It is intended to evaluate 10 premature infants, during 3 observation periods. Heart rate (HR), Respiratory rate (RR) and saturation, pain scale and aEEG sleep wake pattern will be evaluated; first a rest period between feeds as baseline, then with a scare respirator at 20 cycles per minute and finally at 40 cycles per minute. The differences of qualitative and quantitative variables will be assessed with ad-hoc statistical tests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Area Metropolitana
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Santiago, Area Metropolitana, Chile, 833-0024
- Puc, Nicu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hospitalized healthy preterm babies,
- weighing more than 1500g at the time of the study
Exclusion Criteria:
- babies receiving any respiratory support
- carrier of any mayor malformation or genetic condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Babies born Preterm
Preterm babies, healthy at the time of the study, free of neonatal diseases and/or sequelae or malformations or genetic diseases.
They were random assigned to two-hours blocks of basal, and dorsal stimulation protocol at 20 or 40 times per minute, each.
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Basal analysis
To set scare ventilator by 20 cycles per minute
To set scare ventilator by 40 cycles per minute
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)
Time Frame: ten minutes after each intervention starts and every ten minutes for 2 hours straight
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% of time were respiratory rate is synchronised with the scare ventilator input, two tales of statistical differences, at 20 and 40 cycles per minute (cpm)
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ten minutes after each intervention starts and every ten minutes for 2 hours straight
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline newborn HR using the scare ventilator at 20 cpm
Time Frame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
differences in HR mean with two tales of statistical analysis ,between the two study periods
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pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
Change from baseline newborn HR using the scare ventilator at 40 cpm
Time Frame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
differences in HR mean with two tales of statistical analysis ,between the two study periods
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pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm
Time Frame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
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pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm
Time Frame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
|
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
|
pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
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Change from baseline on Discomfort scale using the scare ventilator at 20 cpm
Time Frame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
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Differences with the NIPS average, two tales of statistical differences, between the two study periods (scale 0-12; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain)
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pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
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Change from baseline on Discomfort scale using the scare ventilator at 40 cpm
Time Frame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
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Differences with the NIPS average, two tales of statistical differences, between the two study periods (scale 0-12; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain)
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pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
Change from baseline on RR using the scare ventilator at 20 cpm
Time Frame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
differences in RR mean with two tales of statistical differences between the two periods
|
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
Change from baseline on RR using the scare ventilator at 40 cpm
Time Frame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
differences in RR mean with two tales of statistical differences between the two periods
|
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
Change from baseline on oxygen saturation using the scare ventilator at 20 cpm
Time Frame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
|
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
Change from baseline on oxygen saturation using the scare ventilator at 40 cpm
Time Frame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
|
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paulina Toso, MD, Pontificia Universidad Catolica de Chile
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180926007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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