Clinical trial NCT04584814: Analyze Changes in Respiratory Rate When Using the Scare Respirator
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Newborn
Preterm Labor
Keywords: respiratory rate
scare ventilator
sleep wake cycle
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
Primary purpose: TREATMENT

Brief 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"

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)
timeFrame: ten minutes after each intervention starts and every ten minutes for 2 hours straight
Secondary outcomes:
measure: Change from baseline newborn HR using the scare ventilator at 20 cpm
timeFrame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
measure: Change from baseline newborn HR using the scare ventilator at 40 cpm
timeFrame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
measure: Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm
timeFrame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
measure: Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm
timeFrame: pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight
measure: Change from baseline on Discomfort scale using the scare ventilator at 20 cpm
timeFrame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
measure: Change from baseline on Discomfort scale using the scare ventilator at 40 cpm
timeFrame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
measure: Change from baseline on RR using the scare ventilator at 20 cpm
timeFrame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
measure: Change from baseline on RR using the scare ventilator at 40 cpm
timeFrame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
measure: Change from baseline on oxygen saturation using the scare ventilator at 20 cpm
timeFrame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
measure: Change from baseline on oxygen saturation using the scare ventilator at 40 cpm
timeFrame: pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Puc, Nicu
state: Area Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Paulina Toso, MD
role: PRINCIPAL_INVESTIGATOR
References: