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

NCT06469580 | Recruiting DMC

• 1 other identifier: 36-187 ex 23/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Disease

Keywords

neonatologist performed lung ultrasound; extubation failure; neonates; consolidation

Outcome Measures

Primary Outcomes (1)

• Reintubation rate (within 72 hours after extubation)

  within 72 hours after extubation

Secondary Outcomes (12)

• Mode of respiratory support

  within 72 hours after extubation

• Respiratory settings- FiO2

  within 72 hours after extubation

• Respiratory settings- PEEP

  within 72 hours after extubation

• SpO2/FiO2 ratio

  every hour during 72 hours after extubation

• pH from capillary blood gas analysis

  within 72 hours after extubation

Study Arms (2)

NPLUS group

EXPERIMENTAL

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)

control group

NO INTERVENTION

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.

Interventions

NPLUS (neonatologist performed lung ultrasound) OTHER

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.

NPLUS group

Eligibility Criteria

• Age: 1 Minute - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Pediatrics, Division of Neonatology, Medical University of Graz

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bernhard Schwaberger, MD PhD

  Division of Neonatology, Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Schwaberger, MD PhD

CONTACT

+4331638530018; bernhard.schwaberger@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 21, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

AU (1)