Analyze Changes in Respiratory Rate When Using the Scare Respirator

Preterm Labor Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584814
• Other study ID #: 180926007
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Apnea of Newborn
• Obstetric Labor, Premature
• Preterm Labor

Intervention

Device:
• No intervention
Basal analysis
• scare ventilator at 20
To set scare ventilator by 20 cycles per minute
• scare ventilator at 40
To set scare ventilator by 40 cycles per minute

Locations

Country	Name	City	State
Chile	Puc, Nicu	Santiago	Area Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	ten minutes after each intervention starts and every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
Secondary	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)	pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Secondary	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)	pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Secondary	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	pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight