Mechanical Ventilation ComplicationNCT04957264
Ultrasound for Assessment of Extubation Readiness
An observational study of Mechanical Ventilation Complication and Premature Birth, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Preterm infants are at high-risk for the negative implications of both prolonged mechanical ventilation and extubation failure. Pre-extubation assessments of lung parenchyma and diaphragmatic function of these infants can be useful adjunctive tool for prediction of extubation readiness. Read more about this study
- Who is it for?
- Ages 12 hours and older
- Conditions the study is for
- Mechanical Ventilation Complication, Premature Birth
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2019to 20 May 2022
- 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 12 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants born at < 28 weeks Gestational Age, are admitted to the neonatal intensive care at Mount Sinai Hospital, and receiving invasive mechanical ventilation for at least 12 hours will be eligible for the study.
Who may be able to join
- Infants who are born at < 28 weeks Gestational Age,
- Admitted to the neonatal intensive care at Mount Sinai Hospital
- Receiving invasive mechanical ventilation.
Who cannot join
- Infants who are born at >27 weeks Gestational Age,
- On non-invasive mechanical ventilation
- Infants having congenital or chromosomal abnormalities,
- Infants intubated for < 12 hours
- Infants who have neurological insult, pneumothorax, or under muscle relaxant.
- If parents declined the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Extubation Readiness in Preterm Infants Using Chest Ultrasound
Preterm infants are at high-risk for the negative implications of both prolonged mechanical ventilation and extubation failure. Pre-extubation assessments of lung parenchyma and diaphragmatic function of these infants can be useful adjunctive tool for prediction of extubation readiness.
The aim of this study is to assess the sensitivity and specificity of lung ultrasound and diaphragmatic function evaluation in prediction of extubation readiness in mechanically ventilated neonates born at < 28 weeks gestational age.
Read the detailed description
Study Design and setting:This is a prospective descriptive pilot study that will be conducted on infants born at < 28 weeks gestation who meet eligibility criteria and are admitted to the Neonatal intensive care at Mount Sinai Hospital. Enrolment of eligible infants will start after obtaining approval from Mount Sinai Research Ethics Board and parent's consent.
Time of assessment: Parents of infants on invasive mechanical ventilation who are eligible for the study will be approached for consent. Once the decision made by attending physician to extubate the infant, Chest ultrasound (Lung ultrasound + diaphragmatic function assessment) will be done. Chest ultrasound will be done before next feeding to avoid any interference of a full stomach on diaphragmatic assessment.
Study procedure: Decisions about extubation will be as per the clinical judgment of the physician in-charge of the infant and will not in any way based on Chest ultrasound measurements. A lung ultrasound combined with diaphragmatic function assessment will be done by one of the investigators prior to extubation. The result of Chest ultrasound will be masked for the clinical team to avoid any influence of the Chest ultrasound result on the extubation decision. On the other hand, if the attending physician requests Chest ultrasound for the purpose of the ongoing clinical management or to help with making extubation decision then the result of the study will be disclosed to the physician and this infant will be excluded from the study.
A random sample of 20% of eligible infants will have lung ultrasound scoring and diaphragmatic function assessment done twice by 2 operators (with various levels of Chest ultrasound expertise). None of the operator will be aware of the result of Chest ultrasound done by the other operator for the same patient. Lung ultrasound severity score, diaphragmatic thickness fraction and diaphragmatic excursion will be calculated. Inter-rater agreement will be assessed using raw percentage of agreement (Pa), Cohen's and Kappa (κ), and G wet agreement coefficient (AC1). Intra-class correlation will be determined for variables with continuous measurements (mixed factorial design). High-resolution linear and curvi-linear ultrasound probes of 20-5 and 10-3 MegaHertZ will be used to assess lung ultrasound score and to measure diaphragmatic thickness and diaphragmatic excursion [amplitude] respectively using both B-mode and M-mode.
Lung ultrasound assessment technique: Chest ultrasound will be performed in a standardized manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed. Each area will have a score of 0 to 4 points with the total score ranges from 0 to 24 which inversely correlating with lung aeration.
Diaphragmatic assessment technique: Diaphragm assessment will be performed in the supine position. For measuring diaphragmatic excursion, the curvilinear probe will be placed on the lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right side. Using the B mode, the proper exploration line of the diaphragm will be detected by directing the beam perpendicular to the posterior third of each hemi-diaphragm. By M mode, the cyclic caudal diaphragmatic displacement with respiration will be measured as the perpendicular distance between the most caudal point of the liver or spleen at the end of expiration and the end of inspiration. The average of three respiratory cycles will be taken.
The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the apposition zone which can be obtained by placing the linear transducer above the 10th rib in the mid-axillary or anterior axillary lines in the right intercostal spaces. By B-mode, three distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the maximum perpendicular distance between pleural and peritoneal layers and by the same way expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness Fraction will be calculated using the following formula: diaphragmatic thickness Fraction equal to [(inspiratory thickness _ expiratory thickness)/expiratory thickness] x100. The average of the calculated diaphragmatic thickness Fraction from three respiratory cycles will be estimated. All Chest Ultrasound assessments will be undertaken using a standard aseptic technique.
- Keywords
- Extreme preterm, neonates, Mechanical ventilation, Extubation, chest, Ultrasound
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of chest ultrasound in Prediction of extubation readiness in neonates born at less than 28 weeks gestation.
Chest ultrasound will be performed prior to extubation and Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0-to-4 point will be given for each area. The minimum score = 0 point and the maximum score = 24 points. successful extubation was defined as remained extubated at day 3 post extubation
Measured: 2 year
Secondary outcomes (1)
Assess the Diaphragmatic Thickness Fraction and Diaphragmatic Excursion in preterm infants
- Assessment of Diaphragmatic Thickness in millimetres.
- Assessment of Diaphragmatic Excursion in millimetres.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start22 Oct 2019
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adel Mohamed, MD, Study chair, Mount Sinai Hospital- Toronto, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957264
- Sponsor's protocol ID
- 19-0211-E
- Status last verified
- Oct 2021
- First submitted
- 20 May 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Extubation Readiness in Preterm Infants Using Chest Ultrasound
- ClinicalTrials.gov ID
- NCT04957264
- Acronym / sponsor ID
- 19-0211-E
- Keywords
- Extreme preterm, neonates, Mechanical ventilation, Extubation, chest, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 12 Jul 2021 (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.
Preterm infants are at high-risk for the negative implications of both prolonged mechanical ventilation and extubation failure. Pre-extubation assessments of lung parenchyma and diaphragmatic function of these infants can be useful adjunctive tool for prediction of extubation readiness.
The aim of this study is to assess the sensitivity and specificity of lung ultrasound and diaphragmatic function evaluation in prediction of extubation readiness in mechanically ventilated neonates born at < 28 weeks gestational age.
Detailed description
Study Design and setting:This is a prospective descriptive pilot study that will be conducted on infants born at < 28 weeks gestation who meet eligibility criteria and are admitted to the Neonatal intensive care at Mount Sinai Hospital. Enrolment of eligible infants will start after obtaining approval from Mount Sinai Research Ethics Board and parent's consent.
Time of assessment: Parents of infants on invasive mechanical ventilation who are eligible for the study will be approached for consent. Once the decision made by attending physician to extubate the infant, Chest ultrasound (Lung ultrasound + diaphragmatic function assessment) will be done. Chest ultrasound will be done before next feeding to avoid any interference of a full stomach on diaphragmatic assessment.
Study procedure: Decisions about extubation will be as per the clinical judgment of the physician in-charge of the infant and will not in any way based on Chest ultrasound measurements. A lung ultrasound combined with diaphragmatic function assessment will be done by one of the investigators prior to extubation. The result of Chest ultrasound will be masked for the clinical team to avoid any influence of the Chest ultrasound result on the extubation decision. On the other hand, if the attending physician requests Chest ultrasound for the purpose of the ongoing clinical management or to help with making extubation decision then the result of the study will be disclosed to the physician and this infant will be excluded from the study.
A random sample of 20% of eligible infants will have lung ultrasound scoring and diaphragmatic function assessment done twice by 2 operators (with various levels of Chest ultrasound expertise). None of the operator will be aware of the result of Chest ultrasound done by the other operator for the same patient. Lung ultrasound severity score, diaphragmatic thickness fraction and diaphragmatic excursion will be calculated. Inter-rater agreement will be assessed using raw percentage of agreement (Pa), Cohen's and Kappa (κ), and G wet agreement coefficient (AC1). Intra-class correlation will be determined for variables with continuous measurements (mixed factorial design). High-resolution linear and curvi-linear ultrasound probes of 20-5 and 10-3 MegaHertZ will be used to assess lung ultrasound score and to measure diaphragmatic thickness and diaphragmatic excursion [amplitude] respectively using both B-mode and M-mode.
Lung ultrasound assessment technique: Chest ultrasound will be performed in a standardized manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed. Each area will have a score of 0 to 4 points with the total score ranges from 0 to 24 which inversely correlating with lung aeration.
Diaphragmatic assessment technique: Diaphragm assessment will be performed in the supine position. For measuring diaphragmatic excursion, the curvilinear probe will be placed on the lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right side. Using the B mode, the proper exploration line of the diaphragm will be detected by directing the beam perpendicular to the posterior third of each hemi-diaphragm. By M mode, the cyclic caudal diaphragmatic displacement with respiration will be measured as the perpendicular distance between the most caudal point of the liver or spleen at the end of expiration and the end of inspiration. The average of three respiratory cycles will be taken.
The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the apposition zone which can be obtained by placing the linear transducer above the 10th rib in the mid-axillary or anterior axillary lines in the right intercostal spaces. By B-mode, three distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the maximum perpendicular distance between pleural and peritoneal layers and by the same way expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness Fraction will be calculated using the following formula: diaphragmatic thickness Fraction equal to [(inspiratory thickness _ expiratory thickness)/expiratory thickness] x100. The average of the calculated diaphragmatic thickness Fraction from three respiratory cycles will be estimated. All Chest Ultrasound assessments will be undertaken using a standard aseptic technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants born at < 28 weeks Gestational Age, are admitted to the neonatal intensive care at Mount Sinai Hospital, and receiving invasive mechanical ventilation for at least 12 hours will be eligible for the study.
Key inclusion criteria (3 listed)
- Infants who are born at < 28 weeks Gestational Age,
- Admitted to the neonatal intensive care at Mount Sinai Hospital
- Receiving invasive mechanical ventilation.
Key exclusion criteria (6 listed)
- Infants who are born at >27 weeks Gestational Age,
- On non-invasive mechanical ventilation
- Infants having congenital or chromosomal abnormalities,
- Infants intubated for < 12 hours
- Infants who have neurological insult, pneumothorax, or under muscle relaxant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of chest ultrasound in Prediction of extubation readiness in neonates born at less than 28 weeks gestation.
Time frame: 2 year
Chest ultrasound will be performed prior to extubation and Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0-to-4 point will be given for each area. The minimum score = 0 point and the maximum score = 24 points. successful extubation was defined as remained extubated at day 3 post extubation
1 secondary outcome
Assess the Diaphragmatic Thickness Fraction and Diaphragmatic Excursion in preterm infants
Time frame: 2 year
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 20 Jul 2022.
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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.
Adel Mohamed, MD study chair
Mount Sinai Hospital- Toronto, ON, Canada
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 Mechanical Ventilation Complication and Premature Birth, run by Mount Sinai Hospital, Canada 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 3 inclusion and 6 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 20 Jul 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?
Accuracy of chest ultrasound in Prediction of extubation readiness in neonates born at less than 28 weeks gestation. (time frame: 2 year). 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 20 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.