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

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ClinicalTrials.gov Identifier: NCT01857674
Recruitment Status : Unknown
Verified May 2013 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : May 20, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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.
  • 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.

Condition or disease
Laryngeal Edema Acute Respiratory Failure Requiring Reintubation

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: Evaluation of Laryngeal Ultrasonography Performance in Predicting Major Post Extubation Laryngeal Edema in Intensive Care Patients
Study Start Date : May 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Ultrasound




Primary Outcome Measures :
  1. Performance of laryngeal ultrasonography in predicting major post extubation laryngeal edema in intensive care patients. [ Time Frame: Within the first 24 hours after extubation ]

    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.



Secondary Outcome Measures :
  1. Performance of laryngeal ultrasonography in predicting post-extubation stridor in intensive care patients. [ Time Frame: Within the first 24 hours after extubation ]

    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.


  2. Frequency of major post-extubation laryngeal edema and post-extubation stridor [ Time Frame: Within the first 24 hours after extubation ]
    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.

  3. Risk factors of major post-extubation laryngeal edema in intensive care unit [ Time Frame: From ICU admission to day of inclusion ]
    Several studies have identified risk factor for post-extubation laryngeal edema, but controversy remains.

  4. Evolution of ultrasonic parameters with corticotherapy after reintubation for a major post-extubation laryngeal edema [ Time Frame: Daily from day 1 to day 3 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.

  5. Evaluation of impact of major post-extubation laryngeal edema occurence on mechanical ventilation duration, hospitalization duration and mortality in intensive care unit [ Time Frame: Within 28 days after inclusion in study ]
    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.

  6. Inter-observer reproductibility of ultrasound scanning and ultrasonic air-leak volume measurement [ Time Frame: Day 1 of inclusion ]
    In first 100 included patients,we would perform 2 laryngeal ultrasonograpy to assess inter-observer reproductibility of this new test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All Adults were admitted to the surgical (20 beds) and medical (20 beds)intensive care unit of besançon University Hospital.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857674


Contacts
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Contact: GINET MARC, MD 003338168289 mginet@chu-besancon.fr

Locations
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France
Centre Hospitalier Universitaire Besançon Recruiting
Besançon, France, 25000
Contact: Marc GINET, MD    0033381668289    mginet@chu-besancon.fr   
Principal Investigator: Marc GINET, MD         
Sub-Investigator: Guillaume BESCH, MD         
Sub-Investigator: Sébastien PILI-FLOURY, MD, PhD         
Sub-Investigator: Emmanuel SAMAIN, MD, PhD         
Sub-Investigator: Gilles CAPELLIER, MD, PhD         
Sub-Investigator: Marion COLNOT, Interne         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Publications:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01857674    
Other Study ID Numbers: 2013-A00141-44
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: May 2013
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Laryngeal edema
Post-extubation
Acute respiratory distress
Ultrasonography
Intensive care unit
Additional relevant MeSH terms:
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Respiratory Insufficiency
Laryngeal Edema
Edema
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases