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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584814
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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

Condition or disease Intervention/treatment Phase
Apnea of Newborn Preterm Labor Device: No intervention Device: scare ventilator at 20 Device: scare ventilator at 40 Not Applicable

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 20 NBs, 10 term children and 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 10 term newborns and 10 preterms are going to be put on sequential measures in 2 hours blocks of, no intervention first, followed by 2 hours of scare ventilator setted at 20 cycles per minute, and after that, 2 hours of scare ventilator at 40cycles per minute
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Active Comparator: Babies born Preterm
Preterm babies, healthy at the time of the study , free of neonatal diseases and/or sequelae or malformations or genetic diseases
Device: No intervention
Basal analysis

Device: scare ventilator at 20
To set scare ventilator by 20 cycles per minute

Device: scare ventilator at 40
To set scare ventilator by 40 cycles per minute

Active Comparator: Newborn born at term
Term healthy babies, without respiratory and/or cardiovascular malformations or genetic diseases
Device: No intervention
Basal analysis

Device: scare ventilator at 20
To set scare ventilator by 20 cycles per minute

Device: scare ventilator at 40
To set scare ventilator by 40 cycles per minute




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • hospitalized healthy term or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584814


Contacts
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Contact: Paulina Toso, MD +56223546437 ptoso@med.puc.cl
Contact: Stephanie Campbell, MD +56223546437 fannycampbell@gmail.com

Locations
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Chile
Puc, Nicu Recruiting
Santiago, Area Metropolitana, Chile, 833-0024
Contact: Paulina M Toso, MD    56-2-3546437    ptoso@med.puc.cl   
Principal Investigator: Paulina M Toso, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Paulina Toso, MD Pontificia Universidad Catolica de Chile
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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04584814    
Other Study ID Numbers: 180926007
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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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
Keywords provided by Pontificia Universidad Catolica de Chile:
respiratory rate
scare ventilator
sleep wake cycle
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications