Clinical trial NCT06469580: Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Disease
Keywords: neonatologist performed lung ultrasound
extubation failure
neonates
consolidation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 e.g., 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.

Eligibility criteria: Inclusion Criteria:

* All preterm and full-term neonates receiving invasive mechanical ventilation at the Division of Neonatology of the Medical University of Graz AND
* Written informed consent was obtained from parents prior to extubation

Exclusion Criteria:

none

Primary outcomes:
measure: Reintubation rate (within 72 hours after extubation)
timeFrame: within 72 hours after extubation
Secondary outcomes:
measure: Mode of respiratory support
timeFrame: within 72 hours after extubation
measure: Respiratory settings- FiO2
timeFrame: within 72 hours after extubation
measure: Respiratory settings- PEEP
timeFrame: within 72 hours after extubation
measure: SpO2/FiO2 ratio
timeFrame: every hour during 72 hours after extubation
measure: pH from capillary blood gas analysis
timeFrame: within 72 hours after extubation
measure: Carbon dioxide partial pressure (pCO2)
timeFrame: within 72 hours after extubation
measure: Base Excess (BE)
timeFrame: within 72 hours after extubation
measure: Number of lung imaging
timeFrame: within 72 hours after extubation
measure: Number of lung imaging based interventions
timeFrame: within 72 hours after extubation
measure: Recruitment maneuvers
timeFrame: within 72 hours after extubation
measure: Time to detect consolidations
timeFrame: within 72 hours after extubation
measure: Lung ultrasound scores (LUS)
timeFrame: up to 24 hours after extubation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Pediatrics, Division of Neonatology, Medical University of Graz
state: Styria
Study officials:
affiliation: Division of Neonatology, Medical University of Graz, Austria
name: Bernhard Schwaberger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: