Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469580
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-21
Brief Title:
Neonatologist-performed Lung Ultrasound NPLUS to Guide Respiratory Therapy to Prevent Extubation Failure
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Neonatologist-performed Lung Ultrasound NPLUS to Guide Respiratory Therapy to Prevent Extubation Failure in Term and Preterm Neonates- a Randomized Controlled Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to evaluate the role of neonatologist-performed lung ultrasound NPLUS after weaning from invasive mechanical ventilation and extubation Our aim is to study the diagnostic accuracy of NPLUS and investigate whether LUS leads to earlier actions before clinical deterioration and hence prevents extubation failure
Detailed Description:
In the past few years lung ultrasound has been established as a tool to dynamically assess the lungs in various clinical conditions Standardized protocols have been compiled to allow for an easy and fast evaluation The point-of-care ultrasound POCUS is easily accessible and allows the clinician a readily available bed-side evaluation
Although invasive mechanical ventilation displays a lifesaving strategy in neonatal intensive care it is associated with numerous long-term complications especially in preterm infants Despite a shift to lung-protective ventilation time on mechanical ventilatory support should be kept as short as possible considering timely weaning and switch to a non-invasive ventilation Estimating the right time for discontinuation of invasive mechanical ventilation remains challenging and is influenced by several parameters Extubation failure can be associated with respiratory failure following exhaustion on non-invasive ventilatory support
Collapse of alveolar units lead to hypo-aerated areas Small airway size obstruction due to secretion and muscular weakness predispose to the development of atelectasis in neonates Atelectasis occurring post extubation are a frequent cause of extubation failure Lung consolidations can be sonographically detected A sensitivity of 100 for the detection of neonatal pulmonary atelectasis has been described In recent studies Lung Ultrasound Severity Score LUSS has been shown to be an independent predictor of successful extubation in mechanically ventilated preterm infants However once extubated only limited data is available if extubation failure later in the process can be predicted Lung aeration decreased after extubation to spontaneous breathing
Early standardized evaluation of the lung via lung ultrasound can deliver important information on aeration of the lungs and whether action may be required Using a standardized protocol lung ultrasound score LUS on certain timepoints after extubation can lead to early detection of loss of aeration Timely intervention with eg temporary PEEP increase for alveolar recruitment on non-invasive ventilatory support positioning of the patient prior to clinical deterioration can impede the need of a reintubation and invasive mechanical ventilatory support
Although invasive mechanical ventilation displays a lifesaving strategy in neonatal intensive care it is associated with numerous long-term complications especially in preterm infants Despite a shift to lung-protective ventilation time on mechanical ventilatory support should be kept as short as possible considering timely weaning and switch to a non-invasive ventilation Estimating the right time for discontinuation of invasive mechanical ventilation remains challenging and is influenced by several parameters Extubation failure can be associated with respiratory failure following exhaustion on non-invasive ventilatory support
Collapse of alveolar units lead to hypo-aerated areas Small airway size obstruction due to secretion and muscular weakness predispose to the development of atelectasis in neonates Atelectasis occurring post extubation are a frequent cause of extubation failure Lung consolidations can be sonographically detected A sensitivity of 100 for the detection of neonatal pulmonary atelectasis has been described In recent studies Lung Ultrasound Severity Score LUSS has been shown to be an independent predictor of successful extubation in mechanically ventilated preterm infants However once extubated only limited data is available if extubation failure later in the process can be predicted Lung aeration decreased after extubation to spontaneous breathing
Early standardized evaluation of the lung via lung ultrasound can deliver important information on aeration of the lungs and whether action may be required Using a standardized protocol lung ultrasound score LUS on certain timepoints after extubation can lead to early detection of loss of aeration Timely intervention with eg temporary PEEP increase for alveolar recruitment on non-invasive ventilatory support positioning of the patient prior to clinical deterioration can impede the need of a reintubation and invasive mechanical ventilatory support
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None