Lung Function Monitoring During Hypoxemia Episodes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2026-08-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoxemia of Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm infants with hypoxemia episodes

Very preterm infants with spontaneous HEs and not receiving invasive mechanical ventilation.

Detecting changes in lung volume with hypoxemia episodes

Intervention Type OTHER

Electrical impedance tomography (EIT) will be used to assess changes in lung aeration prior and during hypoxemia episodes to classify them into four different subtypes.

FE subtype: Defined as HEs preceded by reduction in EELI below the baseline.

Apnea subtype: Defined as HEs not meeting the criteria for FE subtype and preceded by cessation of breathing.

Mixed subtype: Defined as HEs meeting the criteria for both FE and apnea subtypes.

Unclassified: Defined as HEs not categorized into any of the above parameters.

Interventions

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Detecting changes in lung volume with hypoxemia episodes

Electrical impedance tomography (EIT) will be used to assess changes in lung aeration prior and during hypoxemia episodes to classify them into four different subtypes.

FE subtype: Defined as HEs preceded by reduction in EELI below the baseline.

Apnea subtype: Defined as HEs not meeting the criteria for FE subtype and preceded by cessation of breathing.

Mixed subtype: Defined as HEs meeting the criteria for both FE and apnea subtypes.

Unclassified: Defined as HEs not categorized into any of the above parameters.

Intervention Type OTHER

Eligibility Criteria

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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 Criteria

* Major congenital malformation
* Receiving invasive mechanical ventilation
* Severe neurological injury
* Hemodynamic instability requiring inotropes in last 72h

Eligible Sex

ALL

Accepts Healthy Volunteers

No