Post-Extubation Assessment of Clinical Stability in ELBW Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography.
- Who it may be relevant to
- Registry conditions: Extremely Low Birth Weight Infants. Basic parameters: up to 28 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study
Overview
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.
Detailed description
The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance of a monitoring system that integrates clinical data and biomedical signals from multiple modalities in a cohort of extremely preterm infants at high-risk of clinical instability on non-invasive respiratory support.
Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely low birth weight infants with or without reintubation during the 7 days post extubation.
The application of this multimodal monitoring approach using both clinical and physiological data during the postextubation period will help by making the assessment of clinical stability more comprehensive, more objective, more accurate, more standardized, and more reflective of important end-organ function. Thus, the proposed multimodal monitoring could lead to more informed decisions about reintubation and more individualized treatment plans during this critical period, hence potentially leading to better outcomes.
Interventions
- Device Oxygen saturation probe
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). - Device Near infrared spectroscopy sensors
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). - Device Electrical impedance tomography
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)
Primary outcome measures
- Recruitment rate [Time frame: 168 hours]
- Consent rate [Time frame: 168 hours]
- Acceptability of the multimodal monitoring approach [Time frame: 168 hours]
Secondary outcome measures (4)
- To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation [Time frame: 168 hours]
- To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation [Time frame: 168 hours]
- To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation [Time frame: 168 hours]
- To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation. [Time frame: 96 hours]
Eligibility criteria
Inclusion criteria
- 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 criteria
\- Congenital anomalies and congenital heart disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 2 centers
- Centre Hospitalier Universitaire Sainte-Justine — Montreal
- McGill University Health Center — Montreal
Identifiers
NCT: NCT06037083 · 2023-8794