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Analyze Changes in Respiratory Rate When Using the Scare Respirator

NCT04584814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-09-21

No results posted yet for this study

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"

Conditions

  • Apnea of Newborn
  • Preterm Labor

Interventions

DEVICE

No intervention

Basal analysis

DEVICE

scare ventilator at 20

To set scare ventilator by 20 cycles per minute

DEVICE

scare ventilator at 40

To set scare ventilator by 40 cycles per minute

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Paulina Toso, MD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-10-31
Completion
2022-03-01
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584814 on ClinicalTrials.gov