Analyze Changes in Respiratory Rate When Using the Scare Respirator

NCT ID: NCT04584814

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-03-01

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.

Conditions

Apnea of Newborn; Preterm Labor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Babies born Preterm

Preterm babies, healthy at the time of the study, free of neonatal diseases and/or sequelae or malformations or genetic diseases. They were random assigned to two-hours blocks of basal, and dorsal stimulation protocol at 20 or 40 times per minute, each.

Group Type: EXPERIMENTAL

No intervention

Intervention Type: DEVICE

Basal analysis

scare ventilator at 20

Intervention Type: DEVICE

To set scare ventilator by 20 cycles per minute

scare ventilator at 40

Intervention Type: DEVICE

To set scare ventilator by 40 cycles per minute

Interventions

No intervention

Basal analysis

Intervention Type: DEVICE

scare ventilator at 20

To set scare ventilator by 20 cycles per minute

Intervention Type: DEVICE

scare ventilator at 40

To set scare ventilator by 40 cycles per minute

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paulina Toso, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Puc, Nicu

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

180926007

Identifier Type: -

Identifier Source: org_study_id