AzTrials
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Laryngeal EdemaECHOLPENCT01857674

Evaluation of Laryngeal Ultrasonography Performance in Predicting Major Post Extubation Laryngeal Edema in Intensive Care Patients

An observational study of Laryngeal Edema and Acute Respiratory Failure Requiring Reintubation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

For patient in intensive care unit, extubation failure is defined as the necessity of early reintubation after scheduled extubation, with Increased morbidity and mortality, so it seems important to quickly identify patients with high risk of post-extubation acute respiratory failure. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
1 siteFrance
Study dates
May 2013to Dec 2014
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 Adults were admitted to the surgical (20 beds) and medical (20 beds)intensive care unit of besançon University Hospital.

Who may be able to join

  • Adults
  • Intubated and ventilated for more than 48 hours.
  • Filling mechanical ventilation weaning criteria according to the 6th consensus conference on intensive care medicine.
  • Affiliated to French Sociale Sécurity.

Who cannot join

  • Pregnant or breast-feeding woman
  • Under 18 or under guardianship patients
  • Laryngeal pathology: benign or malignant tumor, unilateral or bilateral paralysis of recurrent laryngeal nerve, laryngitis
  • Past history of cervical surgery or radiotherapy
  • Technical impossibility of laryngeal ultrasonography: wound or locale infection in ultrasonic plan
  • Self-extubation or accidental extubation
  • Refusal to take part in the study

Trial locations and contacts

1 site in 1 country.

GINET MARC, MD contact

003338168289

mginet@chu-besancon.fr

France1 site, 1 recruiting

  • Centre Hospitalier Universitaire Besançon

    Besançon, 25000

    Marc GINET, MD, 0033381668289, mginet@chu-besancon.fr

    Marc GINET, MD

    Recruiting

Other trials in France

About this study

  • For patient in intensive care unit, extubation failure is defined as the necessity of early reintubation after scheduled extubation, with Increased morbidity and mortality, so it seems important to quickly identify patients with high risk of post-extubation acute respiratory failure.
  • Major post-extubation laryngeal edema is one of extubation failure causes, and its incidence vary in literature from 4 to 37%.
  • We can't currently predict arising of a major post-extubation laryngeal edema. However, a recent pilot study showed that laryngeal ultrasonography could help to identify patients with high risk of post-extubation stridor, measuring ultrasonic leak volume and cuff-deflated air-column width, of which we propose to assess diagnostic performance.
Read the detailed description

Definitions:

Intubation is a traumatism for laryngeal mucous membrane. Due to local inflammatory reaction, laryngeal edema occurs in nearly all intubated patients, but only some of them develop clinical symptoms, as post-extubation stridor or acute respiratory distress. Stridor is commonly defined as a high-pitched sound produced by airflow through a narrowed airway, and accepted as a clinical marker of post-extubation laryngeal edema. The main complication of post-extubation laryngeal edema is reintubation, defining major post-extubation laryngeal edema. Early recognition of laryngeal edema is essential since these patients have the highest risk of evolving to respiratory distress and extubation failure. Even before extubation, signs indicative of laryngeal edema may be present. The search for a test that adequately identifies patients at risk for extubation failure is ongoing.

Trial Procedures:

  • At day 0: Selection of patients filling inclusion criteria. Oral and written information of patient and his refer person, and collecting of non-opposition.
  • At day 0: inclusion of patients ventilated with inspiratory assistance just before schedulded extubation. Information of patient on procedure course.
  • First ultrasonography of protocol: The patient is in the supine position, with the neck hyper-extended, and the probe is placed on cricothyroid membrane with a transverse view of the larynx. The standard scanning plane is predetermined: it should contain several landmarks, including the vocal cords, false cords, thyroid cartilage and arytenoids cartilage. The oral and laryngeal secretions are suctioned. Ultrasonic air-leak volume is defined by difference between air-column width cuff inflated and air-column width cuff deflated. Shape of air-column cuff inflated and cuff deflated is also recorded in observation notebook.
  • Then the patient is extubated after spontaneous ventilation trial, according to unit protocol, by the physician in charge. After extubation, surveillance of post-extubation stridor and acute respiratory distress occurrence during the first 24 hours.
  • If the patient is reintubated for major post-extubation laryngeal edema, onset of 48 hours corticotherapy, and realization of second, third and fourth laryngeal ultrasonography, daily to next schedulded extubation.
  • At discharge of intensive care unit, data collection about mechanical ventilation duration, intensive care hospitalization duration, occurrence of ventilation-acquired pneumopathy, mortality at 28 days.
Keywords
Laryngeal edema, Post-extubation, Acute respiratory distress, Ultrasonography, Intensive care unit
Medical subject headings
Laryngeal Edema, Acute Lung Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of laryngeal ultrasonography in predicting major post extubation laryngeal edema in intensive care patients.

    Sensitivity, specificity, positive predictive value and negative predictive value of ultrasonic air-leak volume in predicting major post-extubation laryngeal edema in intensive care patients.

    A post-extubation laryngeal edema is major when inducing acute respiratory failure requiring early reintubation.

    We assume that, among patients with post-extubation laryngeal edema,the ultrasonic air-leak volume is lower than among patients without post-extubation laryngeal edema.

    Measured: Within the first 24 hours after extubation

Secondary outcomes (6)

  1. Performance of laryngeal ultrasonography in predicting post-extubation stridor in intensive care patients.

    Sensitivity, specificity, positive predictive value and negative predictive value of ultrasonic air-leak volume in predicting post-extubation stridor.

    Post-extubation stridor is commonly defined as a high-pitched sound produced by airflow through a narrowed airway, and is accepted as a clinical marker of laryngeal edema following extubation. So stridor is widely used as outcome measure for post-extubation laryngeal edema.

    Measured: Within the first 24 hours after extubation

  2. Frequency of major post-extubation laryngeal edema and post-extubation stridor

    In literature, incidence of post-extubation stridor is from 2 to 15%, and incidence of major post-extubation laryngeal edema is from 4 to 37%. We would confront incidence of post-extubation laryngeal edema in our cohort and in literature.

    Measured: Within the first 24 hours after extubation

  3. Risk factors of major post-extubation laryngeal edema in intensive care unit

    Several studies have identified risk factor for post-extubation laryngeal edema, but controversy remains.

    Measured: From ICU admission to day of inclusion

  4. Evolution of ultrasonic parameters with corticotherapy after reintubation for a major post-extubation laryngeal edema

    The recommended treatment of major post-extubation laryngeal edema is corticotherapy during 48 hours. By an anti-inflammatory effect, the swelling of laryngeal area decreases under corticoids, so we assume that there is a modification of ultrasonic parameters values during this period.

    Measured: Daily from day 1 to day 3 after reintubation for a major post-extubation laryngeal edema

  5. Evaluation of impact of major post-extubation laryngeal edema occurence on mechanical ventilation duration, hospitalization duration and mortality in intensive care unit

    Occurence of major post-extubation laryngeal edema leads to increase morbidity and mortality because of reintubation and its complications. In our cohort, some patients would need to be reintubate, others don't, so we would confront data between these 2 groups.

    Measured: Within 28 days after inclusion in study

  6. Inter-observer reproductibility of ultrasound scanning and ultrasonic air-leak volume measurement

    In first 100 included patients,we would perform 2 laryngeal ultrasonograpy to assess inter-observer reproductibility of this new test.

    Measured: Day 1 of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionNov 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01857674
Sponsor's protocol ID
2013-A00141-44
Acronym
ECHOLPE
Status last verified
May 2013
First submitted
16 May 2013
Last updated
2 Aug 2013
Results posted
No
Data monitoring committee
No

Publications

  • Ding LW, Wang HC, Wu HD, Chang CJ, Yang PC. Laryngeal ultrasound: a useful method in predicting post-extubation stridor. A pilot study. Eur Respir J. 2006 Feb;27(2):384-9. doi: 10.1183/09031936.06.00029605.

    PubMed 16452597

  • Wittekamp BH, van Mook WN, Tjan DH, Zwaveling JH, Bergmans DC. Clinical review: post-extubation laryngeal edema and extubation failure in critically ill adult patients. Crit Care. 2009;13(6):233. doi: 10.1186/cc8142. Epub 2009 Dec 1.

    PubMed 20017891

  • Sustic A. Role of ultrasound in the airway management of critically ill patients. Crit Care Med. 2007 May;35(5 Suppl):S173-7. doi: 10.1097/01.CCM.0000260628.88402.8A.

    PubMed 17446776

  • Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.

    PubMed 21376523

Questions about this trial

What is this clinical trial studying?

An observational study of Laryngeal Edema and Acute Respiratory Failure Requiring Reintubation, run by Centre Hospitalier Universitaire de Besancon 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 4 inclusion and 7 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 2 Aug 2013. 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 GINET MARC, MD (003338168289, mginet@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of laryngeal ultrasonography in predicting major post extubation laryngeal edema in intensive care patients. (time frame: Within the first 24 hours after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01857674, which also lists 4 linked publications.

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 2 Aug 2013.

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