Puc, Nicu
Santiago, Santiago Metropolitan, 833-0024, Chile
NCT Number: NCT04584814
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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All sexes
Interventional
Not applicable
Santiago, Santiago Metropolitan, 833-0024, Chile
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Basal analysis
To set scare ventilator by 20 cycles per minute
To set scare ventilator by 40 cycles per minute
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)
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
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
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
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
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)
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)
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
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
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
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
Pontificia Universidad Catolica de Chile
Other
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
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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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