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

Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure in Term and Preterm Neonates- a Randomized Controlled Pilot Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Disease
• Intervention / Treatment: Other: NPLUS (neonatologist performed lung ultrasound)

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernhard Schwaberger, MD PhD; Phone Number: +4331638530018; Email: bernhard.schwaberger@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Department of Pediatrics, Division of Neonatology, Medical University of Graz
      • Contact: Viktoria Gruber, MD; Email: vi.gruber@medunigraz.at
      • Contact: Bernhard Schwaberger, MD; Phone Number: 004331638530018; Email: bernhard.schwaberger@medunigraz.at
      • Principal Investigator: Bernhard Schwaberger, MD PhD
      • Sub-Investigator: Viktoria Gruber, MD
      • Sub-Investigator: Nariae Baik-Schneditz, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPLUS group; 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.	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.
No Intervention: control group; Includes routine care in the control group in case of clinical (respiratory) deterioration which is optional chest x-ray or NPLUS at any time point after extubation indicated by the clinician in charge. There are no study-specific measures in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reintubation rate (within 72 hours after extubation)	within 72 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of respiratory support	NCPAP, DUOPAP or BILEVEL during 72 hours after extubation	within 72 hours after extubation
Respiratory settings- FiO2	FiO2 (fraction of inspired oxygen) during 72 hours after extubation	within 72 hours after extubation
Respiratory settings- PEEP	PEEP (Positive EndExpiratory Pressure) during 72 hours after extubation	within 72 hours after extubation
SpO2/FiO2 ratio	Ratio of arterial oxygen saturation and fraction of inspired oxygen	every hour during 72 hours after extubation
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
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
Base Excess (BE)	BE routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation	within 72 hours after extubation
Number of lung imaging	Number of chest X-rays and NPLUS within 72 hours after extubation	within 72 hours after extubation
Number of lung imaging based interventions	Number and time points of chest X-ray or NPLUS based interventions	within 72 hours after extubation
Recruitment maneuvers	Number and time points of recruitment maneuvers (PEEP increase, positioning)	within 72 hours after extubation
Time to detect consolidations	Time to detect impairment of lung aeration (consolidations)	within 72 hours after extubation
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Bernhard Schwaberger, MD PhD, Division of Neonatology, Medical University of Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: neonates; consolidation; extubation failure; neonatologist performed lung ultrasound
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 36-187 ex 23/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No