Laryngeal EdemaREVEALNCT05611437
Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation
An observational study of Laryngeal Edema, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Edema
- What is being tested?
- Ultrafast ultrasonography
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 31 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted in Le Havre Hospital intensive care unit.
Who may be able to join
- Adults,
- Intubated and ventilated for more than 24h,
- Filing mechanical ventilation weaning criteria.
Who cannot join
- Pregnant of breast-feeding woman,
- Under guardianship patient,
- History of laryngeal tumor, stroke, paralysis of recurrent nerve, swallowing disorders,
- History of surgical laryngeal intervention or radiotherapy,
- Unplanned extubation,
- Opposition to take part in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier du Havre
Montivilliers
Clément Medrinal, PhD, +33630039745, clement.medrinal@ch-havre.fr
About this study
In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%.
Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality.
Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.
- Conditions
- Laryngeal Edema
- Being tested
- Ultrafast ultrasonography
- Keywords
- Post-extubation stridor, Intensive care unit, Ultrafast ultrasonography
- Medical subject headings
- Laryngeal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrafast ultrasonographyOther
Ultrasonography of the neck, patient in supine position, neck hyper-extended. Three different scanning planes containing several landmarks. Carried out in the 12h prior extubation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema
A laryngeal edema is defined as a post-extubation stridor. Performance of ultrafast ultrasonography for laryngeal edema prediction in intensive care patients will be assessed with specificity, sensitivity, positive predictive value and negative predictive value.
Measured: Within the 24 hours following extubation
Secondary outcomes (1)
Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders
Performance of ultrafast ultrasonography for swallowing disorsders prediction in intensive care patients will be assessed with specificity, sensitivity, positive predictive value and negative predictive value.
Measured: Within the 24 hours following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Dec 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal EdemaStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611437
- Sponsor's protocol ID
- 2022-A01363-40
- Acronym
- REVEAL
- Status last verified
- Feb 2023
- First submitted
- 10 Oct 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05611437
- Acronym / sponsor ID
- REVEAL / 2022-A01363-40
- Conditions
- Laryngeal Edema
- Keywords
- Post-extubation stridor, Intensive care unit, Ultrafast ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 10 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.
In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%.
Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality.
Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted in Le Havre Hospital intensive care unit.
Key inclusion criteria (3 listed)
- Adults,
- Intubated and ventilated for more than 24h,
- Filing mechanical ventilation weaning criteria.
Key exclusion criteria (6 listed)
- Pregnant of breast-feeding woman,
- Under guardianship patient,
- History of laryngeal tumor, stroke, paralysis of recurrent nerve, swallowing disorders,
- History of surgical laryngeal intervention or radiotherapy,
- Unplanned extubation,
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 |
|---|---|---|
| Ultrafast ultrasonographyUltrasonography of the neck, patient in supine position, neck hyper-extended. Three different scanning planes containing several landmarks. Carried out in the 12h prior extubation. | Other | – |
Primary outcome
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema
Time frame: Within the 24 hours following extubation
A laryngeal edema is defined as a post-extubation stridor. Performance of ultrafast ultrasonography for laryngeal edema prediction in intensive care patients will be assessed with specificity, sensitivity, positive predictive value and negative predictive value.
1 secondary outcome
Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders
Time frame: Within the 24 hours following extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- 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.
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 Laryngeal Edema, run by Groupe Hospitalier du Havre at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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 France. 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 Clement Medrinal (0630039745, medrinal.clement.mk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema (time frame: Within the 24 hours following 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 24 Feb 2023.