NCT06037083

Post-Extubation Assessment of Clinical Stability in ELBW Infants

Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 28 Weeks
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Extremely Low Birth Weight Infants

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-12-31
• Completion: 2027-04-01
• First posted: 2023-09-14
• Last updated: 2026-03-30

Locations

2 sites across 1 country: Canada