Lung Function Monitoring During Hypoxemia Episodes
- Conditions
- Hypoxemia of Newborn
- Interventions
- Other: Detecting changes in lung volume with hypoxemia episodes
- Registration Number
- NCT06535074
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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)
- Major congenital malformation
- Receiving invasive mechanical ventilation
- Severe neurological injury
- Hemodynamic instability requiring inotropes in last 72h
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Preterm infants with hypoxemia episodes Detecting changes in lung volume with hypoxemia episodes Very preterm infants with spontaneous HEs and not receiving invasive mechanical ventilation.
- Primary Outcome Measures
Name Time Method Frequency of hypoxemia episodes of each subtype 6 hour Hypoxemia episodes classified into 4 subtypes of Apnea, forced exhalation, mixed and unclassified according to changes in lung volume parameters.
- Secondary Outcome Measures
Name Time Method Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia 6hr Severe HEs defined as SpO2\<80, Prolonged HEs duration\>=30s, Bradycardia HR\<100 for \>=5s
Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes 6hr Episodes meeting the EIT criteria for FE and apnea but not associated with HEs
Mean highest change in CrSO2 and cFToE during HEs and each subtype 6hr Change in CrSO2 from baseline and fTOE during HEs
Trial Locations
- Locations (1)
Bristol Myers Squibbs Childrens Hospital
🇺🇸New Brunswick, New Jersey, United States