Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535074
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Lung Function Monitoring During Hypoxemia Episodes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None