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Analyze Changes in Respiratory Rate When Using the Scare Respirator (RESPSUS)

Primary Purpose

Apnea of Newborn, Preterm Labor

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
No intervention
scare ventilator at 20
scare ventilator at 40
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea of Newborn focused on measuring respiratory rate, scare ventilator, sleep wake cycle

Eligibility Criteria

1 Day - 1 Month (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Puc, Nicu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Babies born Preterm

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)
% 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)

Secondary Outcome Measures

Change from baseline newborn HR using the scare ventilator at 20 cpm
differences in HR mean with two tales of statistical analysis ,between the two study periods
Change from baseline newborn HR using the scare ventilator at 40 cpm
differences in HR mean with two tales of statistical analysis ,between the two study periods
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
Change from baseline on Discomfort scale using the scare ventilator at 20 cpm
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)
Change from baseline on Discomfort scale using the scare ventilator at 40 cpm
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)
Change from baseline on RR using the scare ventilator at 20 cpm
differences in RR mean with two tales of statistical differences between the two periods
Change from baseline on RR using the scare ventilator at 40 cpm
differences in RR mean with two tales of statistical differences between the two periods
Change from baseline on oxygen saturation using the scare ventilator at 20 cpm
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
Change from baseline on oxygen saturation using the scare ventilator at 40 cpm
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods

Full Information

First Posted
August 21, 2020
Last Updated
September 16, 2022
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04584814
Brief Title
Analyze Changes in Respiratory Rate When Using the Scare Respirator
Acronym
RESPSUS
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator"
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Newborn, Preterm Labor
Keywords
respiratory rate, scare ventilator, sleep wake cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Babies born Preterm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
No intervention
Intervention Description
Basal analysis
Intervention Type
Device
Intervention Name(s)
scare ventilator at 20
Intervention Description
To set scare ventilator by 20 cycles per minute
Intervention Type
Device
Intervention Name(s)
scare ventilator at 40
Intervention Description
To set scare ventilator by 40 cycles per minute
Primary Outcome Measure Information:
Title
Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)
Description
% 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)
Time Frame
ten minutes after each intervention starts and every ten minutes for 2 hours straight
Secondary Outcome Measure Information:
Title
Change from baseline newborn HR using the scare ventilator at 20 cpm
Description
differences in HR mean with two tales of statistical analysis ,between the two study periods
Time Frame
pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Title
Change from baseline newborn HR using the scare ventilator at 40 cpm
Description
differences in HR mean with two tales of statistical analysis ,between the two study periods
Time Frame
pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Title
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm
Description
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
Time Frame
pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Title
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm
Description
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
Time Frame
pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Title
Change from baseline on Discomfort scale using the scare ventilator at 20 cpm
Description
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)
Time Frame
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Title
Change from baseline on Discomfort scale using the scare ventilator at 40 cpm
Description
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)
Time Frame
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Title
Change from baseline on RR using the scare ventilator at 20 cpm
Description
differences in RR mean with two tales of statistical differences between the two periods
Time Frame
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Title
Change from baseline on RR using the scare ventilator at 40 cpm
Description
differences in RR mean with two tales of statistical differences between the two periods
Time Frame
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Title
Change from baseline on oxygen saturation using the scare ventilator at 20 cpm
Description
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
Time Frame
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Title
Change from baseline on oxygen saturation using the scare ventilator at 40 cpm
Description
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
Time Frame
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Toso, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puc, Nicu
City
Santiago
State/Province
Area Metropolitana
ZIP/Postal Code
833-0024
Country
Chile

12. IPD Sharing Statement

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