no ConditionsLUSENCT05628753
Lung Ultrasound as a Predictor for Successful Extubation in Preterm Infants
An observational study of no Conditions, run by Royal University Hospital, Saskatoon at 1 site in Canada.
Trial summary
unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- no Conditions
- What is being tested?
- Lung Ultrasound (LUS)
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2019to 1 Sep 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Invasively ventilated infants born before 32 weeks of gestational age
Who may be able to join
- Invasively ventilated infants born at less than 32 weeks of gestational age were included at the time of their first extubation
Who cannot join
- infants born after 32 weeks of gestational age
Trial locations and contacts
1 site in 1 country.
About this study
unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Hatch et al (2016) in their prospective study on 162 infants described adverse events in 40% of intubations and severe complications including need for CPR in 9%. Reintubations are frequently associated with hypoxemia, bradycardia, fluctuations in blood pressures and cerebral perfusion. Each intubation attempt increases the risk of traumatic injury to the upper airway, lung atelectasis and infections. Thus, there is a clear need to establish objective criteria that would help avoid extubation failure and the need for reintubation.
In recent years, a new imaging application has been introduced in neonatal practice-lung ultrasound (LUS), an accurate and reliable technique for the lung evaluation. LUS is safe, non-ionizing, easy to operate, and low-cost tool. The evaluation of lungs is performed in real-time, on the bedside and without anesthetic drugs. Lung aeration could be assessed in dynamics without extra radiation to the infant. Ultrasound findings combined with clinical information could be used for the prognosis of successful extubation in premature infants.
Read the detailed description
Mechanical ventilation (MV) is a widely used therapeutic resource in neonatal intensive care unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Hatch et al (2016) in their prospective study on 162 infants described adverse events in 40% of intubations and severe complications including need for CPR in 9%. Reintubations are frequently associated with hypoxemia, bradycardia, fluctuations in blood pressures and cerebral perfusion. Each intubation attempt increases the risk of traumatic injury to the upper airway, lung atelectasis and infections. Thus, there is a clear need to establish objective criteria that would help avoid extubation failure and the need for reintubation.
Currently used criteria for extubation are subjective and based on clinical evaluation, chest radiograph findings, amount of ventilatory support and arterial blood gas (ABG) parameters. An accurate bedside test for extubation readiness in preterm infants born is even more important as this population is more susceptible to the complications of re-intubation. There are several studies that showed that reintubation after elective extubation is independently associated with increased likelihood of death and BPD in extremely preterm infants. The greatest risks are attributable to reintubation within the first 48 hours post-extubation.
Several studies have shown that a low lung volume and small chest radiograph lung area after extubation could predict extubation failure. Infants who have a low lung volume after extubation may have an unfavourable balance between respiratory muscle strength and respiratory load. Ideally, these infants should be identified before removal of the endotracheal tube.
In recent years, a new imaging application has been introduced in neonatal practice-lung ultrasound (LUS), an accurate and reliable technique for the lung evaluation. LUS is safe, non-ionizing, easy to operate, and low-cost tool. The evaluation of lungs is performed in real-time, on the bedside and without anesthetic drugs. Lung aeration could be assessed in dynamics without extra radiation to the infant. Ultrasound findings combined with clinical information could be used for the prognosis of successful extubation in premature infants.
- Conditions
- no Conditions
- Being tested
- Lung Ultrasound (LUS)
- Keywords
- Lung ultrasound, Prematurity, RDS, Mechanical ventilation, Extubation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound (LUS)Diagnostic test
LUS performed 30 mins prior to and 120 minutes after planned extubation with a linear high frequency probe longitudinal approach was used in all three zones Repeated third scan will be done prior to re-intubation (if required) The ultrasound total execution cut-off time expected to be less than 5 minutes
What is being measured
The primary outcome is the main question the study is designed to answer.
lung aeration before and after extubation by comparing LUS indexes
Measured: 30 minutes
re-intubation within 12, 36 or 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start14 Jul 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no ConditionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal University Hospital, Saskatoon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628753
- Sponsor's protocol ID
- Bio ID 1451
- Acronym
- LUSE
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound as a Predictor for Successful Extubation in Preterm Infants
- ClinicalTrials.gov ID
- NCT05628753
- Acronym / sponsor ID
- LUSE / Bio ID 1451
- Conditions
- no Conditions
- Keywords
- Lung ultrasound, Prematurity, RDS, Mechanical ventilation, Extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royal University Hospital, SaskatoonUniversity, hospital or other
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 29 Nov 2022 (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.
unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Hatch et al (2016) in their prospective study on 162 infants described adverse events in 40% of intubations and severe complications including need for CPR in 9%. Reintubations are frequently associated with hypoxemia, bradycardia, fluctuations in blood pressures and cerebral perfusion. Each intubation attempt increases the risk of traumatic injury to the upper airway, lung atelectasis and infections. Thus, there is a clear need to establish objective criteria that would help avoid extubation failure and the need for reintubation.
In recent years, a new imaging application has been introduced in neonatal practice-lung ultrasound (LUS), an accurate and reliable technique for the lung evaluation. LUS is safe, non-ionizing, easy to operate, and low-cost tool. The evaluation of lungs is performed in real-time, on the bedside and without anesthetic drugs. Lung aeration could be assessed in dynamics without extra radiation to the infant. Ultrasound findings combined with clinical information could be used for the prognosis of successful extubation in premature infants.
Detailed description
Mechanical ventilation (MV) is a widely used therapeutic resource in neonatal intensive care unit (NICU); however prolonged MV is known to be associated with serious complications including ventilator associated pneumonia, blood stream infections, bronchopulmonary dysplasia (BPD) and periventricular leukomalacia. At the same time, extubation failure increases morbidities and mortality. Hatch et al (2016) in their prospective study on 162 infants described adverse events in 40% of intubations and severe complications including need for CPR in 9%. Reintubations are frequently associated with hypoxemia, bradycardia, fluctuations in blood pressures and cerebral perfusion. Each intubation attempt increases the risk of traumatic injury to the upper airway, lung atelectasis and infections. Thus, there is a clear need to establish objective criteria that would help avoid extubation failure and the need for reintubation.
Currently used criteria for extubation are subjective and based on clinical evaluation, chest radiograph findings, amount of ventilatory support and arterial blood gas (ABG) parameters. An accurate bedside test for extubation readiness in preterm infants born is even more important as this population is more susceptible to the complications of re-intubation. There are several studies that showed that reintubation after elective extubation is independently associated with increased likelihood of death and BPD in extremely preterm infants. The greatest risks are attributable to reintubation within the first 48 hours post-extubation.
Several studies have shown that a low lung volume and small chest radiograph lung area after extubation could predict extubation failure. Infants who have a low lung volume after extubation may have an unfavourable balance between respiratory muscle strength and respiratory load. Ideally, these infants should be identified before removal of the endotracheal tube.
In recent years, a new imaging application has been introduced in neonatal practice-lung ultrasound (LUS), an accurate and reliable technique for the lung evaluation. LUS is safe, non-ionizing, easy to operate, and low-cost tool. The evaluation of lungs is performed in real-time, on the bedside and without anesthetic drugs. Lung aeration could be assessed in dynamics without extra radiation to the infant. Ultrasound findings combined with clinical information could be used for the prognosis of successful extubation in premature infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invasively ventilated infants born before 32 weeks of gestational age
Key inclusion criteria (1 listed)
- Invasively ventilated infants born at less than 32 weeks of gestational age were included at the time of their first extubation
Key exclusion criteria (1 listed)
- infants born after 32 weeks of gestational age
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 |
|---|---|---|
| Lung Ultrasound (LUS)LUS performed 30 mins prior to and 120 minutes after planned extubation with a linear high frequency probe longitudinal approach was used in all three zones Repeated third scan will be done prior to re-intubation (if required) The ultrasound total execution cut-off time expected to be less than 5 minutes | Diagnostic test | – |
Primary outcome
lung aeration before and after extubation by comparing LUS indexes
Time frame: 30 minutes
re-intubation within 12, 36 or 72 hours
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of no Conditions, run by Royal University Hospital, Saskatoon at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 29 Nov 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung aeration before and after extubation by comparing LUS indexes (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 29 Nov 2022.