Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure

Not Applicable

Recruiting

• Conditions: Neonatal Disease
• Interventions: Other: NPLUS (neonatologist performed lung ultrasound)

• Registration Number: NCT06469580
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2024-05-21
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPLUS group	NPLUS (neonatologist performed lung ultrasound)	In the NPLUS group (intervention group) lung ultrasound is performed at time point T0 (prior to extubation), T1 (2-4 hours post extubation) and time point T2 (16-24 h) post extubation.

Primary Outcome Measures

Name	Time	Method
Reintubation rate (within 72 hours after extubation)	within 72 hours after extubation

Secondary Outcome Measures

Name	Time	Method
Time to detect consolidations	within 72 hours after extubation	Time to detect impairment of lung aeration (consolidations)
Mode of respiratory support	within 72 hours after extubation	NCPAP, DUOPAP or BILEVEL during 72 hours after extubation
Respiratory settings- FiO2	within 72 hours after extubation	FiO2 (fraction of inspired oxygen) during 72 hours after extubation
Number of lung imaging based interventions	within 72 hours after extubation	Number and time points of chest X-ray or NPLUS based interventions
Lung ultrasound scores (LUS)	up to 24 hours after extubation	LUS at time point T0 (prior to extubation), T1 (2-4 hours post extubation) and time point T2 (16-24 h post extubation)
Respiratory settings- PEEP	within 72 hours after extubation	PEEP (Positive EndExpiratory Pressure) during 72 hours after extubation
Carbon dioxide partial pressure (pCO2)	within 72 hours after extubation	pCO2 Routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation
SpO2/FiO2 ratio	every hour during 72 hours after extubation	Ratio of arterial oxygen saturation and fraction of inspired oxygen
pH from capillary blood gas analysis	within 72 hours after extubation	pH routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation
Number of lung imaging	within 72 hours after extubation	Number of chest X-rays and NPLUS within 72 hours after extubation
Recruitment maneuvers	within 72 hours after extubation	Number and time points of recruitment maneuvers (PEEP increase, positioning)
Base Excess (BE)	within 72 hours after extubation	BE routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation

Trial Locations

Locations (1)

Department of Pediatrics, Division of Neonatology, Medical University of Graz; 🇦🇹 Graz, Styria, Austria