Ultrasonography vs airway endoscopy for the assessment of vocal fold function and subglottic airway patency prior to tracheostomy decannulation in tracheostomized children. A prospective observational study.

Brief description of the proposal

Title: Ultrasonography vs airway endoscopy for the assessment of vocal fold function and subglottic airway patency prior to tracheostomy decannulation in tracheostomized children. A prospective observational pilot study.

Introduction

Tracheostomy is an important airway management modality in the intensive care of patients requiring prolonged ventilation. Irrespective of the primary indication, and duration of tracheostomy status, removal of the tracheostomy tube can only be safely performed after assessment of the airway above the level of the tracheostoma. This is particularly important in the pediatric population as children have a limited pulmonary reserve. Inadequate assessment often results in failed decannulation, aspiration and related complications, revision tracheostomies and even death. Conventionally, the airway assessment includes assessment of the vocal fold mobility and assessment of the subglottic airway by using a rigid or flexible endoscope or bronchoscope. However, this procedure often requires sedation or general anesthesia depending up on the age and general condition of the patient. Ultrasonographic assessment of the airway is a noninvasive and painless procedure which can be done without any sedation and might be able to better assess vocal fold mobility. The aim of this study is to compare the usefulness of ultrasonography vs airway endoscopy for the assessment of vocal fold function and subglottic airway patency prior to tracheostomy decannulation in tracheostomized children.

Rationale and Justification

Assessment of the airway superior to the tracheostoma is mandatory before decannulation in pediatric patients with tracheostomy. Currently, the recommended technique of airway assessment is direct laryngoscopic or endoscopic assessment of vocal fold function and subglottic area. This procedure often requires sedation or even general anesthesia in children and is done in the ICU or operation theatre. Under general anesthesia, assessment of vocal fold function may be prone to errors as well. Ultrasound of the airway is done without sedation or anesthesia as it is painless and noninvasive. It might provide better information about the vocal cord mobility as well. Hence, we propose to evaluate the efficacy of ultrasound in the assessment of the vocal fold function and subglottic airway patency prior to tracheostomy decannulation in tracheostomized children in comparison with airway endoscopy.

Aim

The aim of this study is to compare the usefulness of ultrasonography vs airway endoscopy for the assessment of vocal fold function and subglottic airway patency prior to tracheostomy decannulation in tracheostomized children.

Objectives

1. To perform assessment of the vocal cord mobility using airway endoscopy and ultrasonography and compare the findings in tracheostomized pediatric patients planned for decannulation.

2.To perform assessment of the supraglottic, subglottic and tracheal airway using airway endoscopy and ultrasonography and compare the findings in tracheostomized pediatric patients planned for decannulation.

3. To evaluate interobserver concordance about vocal cord mobility and supraglottic, subglottic and tracheal airway patency by ultrasonography.

Research Design, Methodology and Tools:

Study design: This is a prospective observational study.

Setting: Study will be conducted by the Departments of Otorhinolaryngology, Head &Neck Surgery, Anaesthesiology and Critical Care, Radiodiagnosis, and Paediatrics, at AIIMS, Bathinda.

Methods: After Research cell and Ethics committee approval 30 tracheostomized children admitted in the hospital under various departments planned for decannulation will be included in this study after obtaining informed consent from parents/guardians and assent from older children.

Procedure: Airway endoscopy will be done in the operating theatre or ICU depending upon the patient profile as deemed fit by the clinical team. In addition, ultrasonographic evaluation of the airway will also be done by a qualified radiologist and anesthesiologist with experience in airway ultrasound at two different settings.

Outcome measures:

Primary outcome measure: Agreement between airway endoscopy and ultrasonography in the assessment of vocal cord mobility and subglottic airway patency.

Secondary outcome measures:

i.       Patient parameters determining rate of success in airway endoscopy.

ii.     Cost effectiveness of ultrasound vs airway endoscopy for planning tracheostomy decannulation.

Statistical analysis: Data will be analyzed using latest version of SPSS or similar software.

Significance: If ultrasonography is found to be as effective of better than airway endoscopy, patients may be decannulated without subjecting them to general anesthesia and invasive airway assessment while simultaneously reducing costs and also saving valuable OR time.