Lung Function Monitoring During Hypoxemia Episodes

Last updated: July 30, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Detecting changes in lung volume with hypoxemia episodes

Clinical Study ID

NCT06535074
Pro2023000655
  • All Genders

Study Summary

Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Born at ≤32w GA

  • Post menstrual age between 30w to 36w

  • 4 or more episodes of HEs in the previous 24h (Defined as SpO2<90≥5s)

Exclusion

Exclusion Criteria:

  • Major congenital malformation

  • Receiving invasive mechanical ventilation

  • Severe neurological injury

  • Hemodynamic instability requiring inotropes in last 72h

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Detecting changes in lung volume with hypoxemia episodes
Phase:
Study Start date:
April 04, 2024
Estimated Completion Date:
August 04, 2026

Study Description

This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.

Connect with a study center

  • Bristol Myers Squibbs Childrens Hospital

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

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