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Completed

NCT Number: NCT04584814

Analyze Changes in Respiratory Rate When Using the Scare Respirator

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"

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Key information

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puc, Nicu

Santiago, Santiago Metropolitan, 833-0024, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention

Device

Basal analysis

scare ventilator at 20

Device

To set scare ventilator by 20 cycles per minute

scare ventilator at 40

Device

To set scare ventilator by 40 cycles per minute

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study 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)

Acronym: RESPSUS

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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