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)

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

• Status: Completed
• Conditions: Preterm Labor; Apnea of Newborn
• Intervention / Treatment: Device: scare ventilator at 20; Device: scare ventilator at 40; Device: without any device

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

Study Locations

• Chile
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 833-0024
      • Puc, Nicu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- hospitalized healthy preterm babies,

Exclusion Criteria:

• babies receiving mechanical ventilation
• carrier of any mayor malformation or genetic condition
• sick or having an thorax or abdomen surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Prematures basal; Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings basal, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes	Device: without any device; Basal analysis
Active Comparator: 20 x min pulsatil stimuli; Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings, with 20xmin min dorsal pulsatil stimuly, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes	Device: scare ventilator at 20; To set scare ventilator by 20 cycles per minute
Active Comparator: 20x min pulsatil stimuli; Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings, basal, with 20xmin and 40x min dorsal pulsatil stimuly, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes	Device: scare ventilator at 40; 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)	% 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)	2 hours interfedings at the study day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
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	2 hours interfedings at the study day
Adverse events	Register and look active for adverse events during interventions	From enrollment to the end of the hospitalization time
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 0-10; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain)	2 hours interfedings at the study day
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 0-10; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain)	2 hours interfedings at the study day

Collaborators and Investigators

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

Study record dates

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): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: respiratory rate; scare ventilator; sleep wake cycle
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Obstetric Labor, Premature
• Other Study ID Numbers: 180926007

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