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

NCT01857674 | Unknown

• 1 other identifier: 2013-A00141-44
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Edema; Acute Respiratory Failure Requiring Reintubation

Keywords

Laryngeal edema; Post-extubation; Acute respiratory distress; Ultrasonography; Intensive care unit

Outcome Measures

Primary Outcomes (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.

  Within the first 24 hours after extubation

Secondary Outcomes (6)

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

  Within the first 24 hours after extubation

• Frequency of major post-extubation laryngeal edema and post-extubation stridor

  Within the first 24 hours after extubation

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

  From ICU admission to day of inclusion

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

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

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

  Within 28 days after inclusion in study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire Besançon

Besançon, 25000, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 16452597 BACKGROUND

• 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.

  PMID: 20017891 BACKGROUND

• 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.

  PMID: 17446776 BACKGROUND

• 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.

  PMID: 21376523 BACKGROUND

MeSH Terms

Conditions

Laryngeal Edema; Acute Lung Injury

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Lung Injury; Lung Diseases

Central Study Contacts

GINET MARC, MD

CONTACT

003338168289; mginet@chu-besancon.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 2, 2013

Record last verified: 2013-05

Locations

FR (1)