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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorMedical University of Graz

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • NPLUS (neonatologist performed lung ultrasound)

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NPLUS groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reintubation rate (within 72 hours after extubation)

Time frame
within 72 hours after extubation

Secondary outcomes

1

Mode of respiratory support

NCPAP, DUOPAP or BILEVEL during 72 hours after extubation

Time frame
within 72 hours after extubation
2

Respiratory settings- FiO2

FiO2 (fraction of inspired oxygen) during 72 hours after extubation

Time frame
within 72 hours after extubation
3

Respiratory settings- PEEP

PEEP (Positive EndExpiratory Pressure) during 72 hours after extubation

Time frame
within 72 hours after extubation
4

SpO2/FiO2 ratio

Ratio of arterial oxygen saturation and fraction of inspired oxygen

Time frame
every hour during 72 hours after extubation

Other outcomes

Sponsors and contacts

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