Lung Function Monitoring During Hypoxemia Episodes

Официальное название

Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Frequency of hypoxemia episodes of each subtype [Срок оценки: 6 hour]

Вторичные конечные точки (3)

• Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia [Срок оценки: 6hr]
• Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes [Срок оценки: 6hr]
• Mean highest change in CrSO2 and cFToE during HEs and each subtype [Срок оценки: 6hr]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Bristol Myers Squibbs Childrens Hospital — New Brunswick

Публикации

• Bancalari E, Claure N. Respiratory Instability and Hypoxemia Episodes in Preterm Infants. Am J Perinatol. 2018 May;35(6):534-536. doi: 10.1055/s-0038-1637760. Epub 2018 Apr 25. PMID 29694990
• Bolivar JM, Gerhardt T, Gonzalez A, Hummler H, Claure N, Everett R, Bancalari E. Mechanisms for episodes of hypoxemia in preterm infants undergoing mechanical ventilation. J Pediatr. 1995 Nov;127(5):767-73. doi: 10.1016/s0022-3476(95)70171-0. PMID 7472834
• Esquer C, Claure N, D'Ugard C, Wada Y, Bancalari E. Role of abdominal muscles activity on duration and severity of hypoxemia episodes in mechanically ventilated preterm infants. Neonatology. 2007;92(3):182-6. doi: 10.1159/000102056. Epub 2007 Apr 27. PMID 17476118
• van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230. PMID 24561568
• Piraino T. An Introduction to the Clinical Application and Interpretation of Electrical Impedance Tomography. Respir Care. 2022 Jun;67(6):721-729. doi: 10.4187/respcare.09949. PMID 35606004

Идентификаторы

NCT: NCT06535074 · Pro2023000655

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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