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

Neonatal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06469580
• Other study ID #: 36-187 ex 23/24
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Medical University of Graz
• Contact: Bernhard Schwaberger, MD PhD
• Phone: +4331638530018
• Email: bernhard.schwaberger[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease

Intervention

Other:
• NPLUS (neonatologist performed lung ultrasound)
NPLUS is conducted with an ultrasound scanner using a high-frequency (12-15 MHz) linear transducer probe (scanning depth approximately 4-5 cm). The neonate is placed in a supine position. The anterior, lateral and posterior chest areas are scanned using the presets "lung" or "small parts". Landmarks are the anterior and posterior axillary line (longitudinal) on each hemithorax. A sequential scan from right to left, anterior to posterior is performed. (6 lung areas). In the study NPLUS is performed to quantify the lung ultrasound score at time points T0, T1 and T2. Sequences of 3-5 seconds are saved and assessed according to the lung ultrasound score adapted by Rodriguez-Fanjul et al. (0- to 3 point score for each area, resulting in a total score ranging from 0 to 18). To ensure inter-observer reliability the anonymous video sequences are then rated by two independent neonatologists.

Locations

Country	Name	City	State
Austria	Department of Pediatrics, Division of Neonatology, Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

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