Post-Extubation Assessment of Clinical Stability in ELBW Infants
Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study
McGill University Health Centre/Research Institute of the McGill University Health Centre
20 participants
Oct 29, 2024
OBSERVATIONAL
Conditions
Summary
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.
Eligibility
Inclusion Criteria3
- Birth weight \< 1000g and gestational age \< 28+0 weeks,
- Received mechanical ventilation within the first 72h of life,
- Undergoing their first planned extubation within the first 6 weeks of life.
Exclusion Criteria1
- \- Congenital anomalies and congenital heart disorders.
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Interventions
The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).
The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).
The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points: * From 1 hour pre-extubation to 2 hours post extubation (total 3 hours) * Between 24 and 48 hours post extubation (total 3 hours) * Between 72 and 96 hours post extubation (total 3 hours)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06037083