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

September 16, 2022 updated by: Pontificia Universidad Catolica de Chile

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)

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"

Study Overview

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Area Metropolitana
      • Santiago, Area Metropolitana, Chile, 833-0024
        • Puc, Nicu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Basal analysis
To set scare ventilator by 20 cycles per minute
To set scare ventilator by 40 cycles per minute

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
% 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)
ten minutes after each intervention starts and every ten minutes for 2 hours straight

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
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
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
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
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
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)
pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
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
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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paulina Toso, MD, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

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

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.

Clinical Trials on Preterm Labor

Clinical Trials on No intervention

3
Subscribe