Neonatal DiseaseNCT06469580
Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure
A study testing NPLUS (neonatologist performed lung ultrasound) in people with Neonatal Disease, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 1 minute to 6 months
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- NPLUS (neonatologist performed lung ultrasound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, 8036
Viktoria Gruber, MD, vi.gruber@medunigraz.at
Bernhard Schwaberger, MD, 004331638530018, bernhard.schwaberger@medunigraz.at
About this study
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
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.
Read the 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.
- Conditions
- Neonatal Disease
- Being tested
- NPLUS (neonatologist performed lung ultrasound)
- Keywords
- neonatologist performed lung ultrasound, extubation failure, neonates, consolidation
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation rate (within 72 hours after extubation)
Measured: within 72 hours after extubation
Secondary outcomes (12)
Mode of respiratory support
NCPAP, DUOPAP or BILEVEL during 72 hours after extubation
Measured: within 72 hours after extubation
Respiratory settings- FiO2
FiO2 (fraction of inspired oxygen) during 72 hours after extubation
Measured: within 72 hours after extubation
Respiratory settings- PEEP
PEEP (Positive EndExpiratory Pressure) during 72 hours after extubation
Measured: within 72 hours after extubation
SpO2/FiO2 ratio
Ratio of arterial oxygen saturation and fraction of inspired oxygen
Measured: 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
Measured: 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
Measured: within 72 hours after extubation
Base Excess (BE)
BE routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation
Measured: within 72 hours after extubation
Number of lung imaging
Number of chest X-rays and NPLUS within 72 hours after extubation
Measured: within 72 hours after extubation
Number of lung imaging based interventions
Number and time points of chest X-ray or NPLUS based interventions
Measured: within 72 hours after extubation
Recruitment maneuvers
Number and time points of recruitment maneuvers (PEEP increase, positioning)
Measured: within 72 hours after extubation
Time to detect consolidations
Time to detect impairment of lung aeration (consolidations)
Measured: 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)
Measured: up to 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jun 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernhard Schwaberger, MD PhD, Principal investigator, Division of Neonatology, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469580
- Sponsor's protocol ID
- 36-187 ex 23/24
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06469580
- Acronym / sponsor ID
- 36-187 ex 23/24
- Conditions
- Neonatal Disease
- Keywords
- neonatologist performed lung ultrasound, extubation failure, neonates, consolidation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPLUS group | Experimental | Other: 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. |
| 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. |
Who may qualify
- Ages
- 1 minute to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | NPLUS group |
Primary outcome
Reintubation rate (within 72 hours after extubation)
Time frame: within 72 hours after extubation
12 secondary outcomes
Mode of respiratory support
Time frame: within 72 hours after extubation
Respiratory settings- FiO2
Time frame: within 72 hours after extubation
Respiratory settings- PEEP
Time frame: within 72 hours after extubation
SpO2/FiO2 ratio
Time frame: every hour during 72 hours after extubation
pH from capillary blood gas analysis
Time frame: within 72 hours after extubation
Carbon dioxide partial pressure (pCO2)
Time frame: within 72 hours after extubation
Base Excess (BE)
Time frame: within 72 hours after extubation
Number of lung imaging
Time frame: within 72 hours after extubation
Number of lung imaging based interventions
Time frame: within 72 hours after extubation
Recruitment maneuvers
Time frame: within 72 hours after extubation
Time to detect consolidations
Time frame: within 72 hours after extubation
Lung ultrasound scores (LUS)
Time frame: up to 24 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Schwaberger, MD PhD principal investigator
Division of Neonatology, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPLUS (neonatologist performed lung ultrasound) in people with Neonatal Disease, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Schwaberger, MD PhD (+4331638530018, bernhard.schwaberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation rate (within 72 hours after extubation) (time frame: within 72 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.