Dysphagia Clinical Trial
Official title:
Incidence of Dysphagia in Intensive Care Patients With Tracheostomy Using High Resolution Pharyngoesophageal Manometry and Impedance
This study will inform the feasibility of the High Resolution Impedance Manometry (HRIM) system combined with Automated Impedance Manometry (AIM) analysis as a screening tool for dysphagia and aspiration for the intensive care population with tracheostomy. This pilot study aims to determine the incidence of dysphagia and aspiration risk in intensive care patients with tracheostomy and the investigators hypothesise that the incidence of dysphagia in intensive care patients with tracheostomy will be higher than in an age matched population.
Aspiration pneumonia is a common mechanism for recurrent mechanical ventilation episodes in
intensive care patients and leads to longer hospital admissions, increased morbidity, and
mortality. When length of the mechanical ventilation is prolonged the translaryngeal tube is
changed to a tracheostomy tube. This practice has several advantages: further pressure
damage to the vocal cords is avoided, weaning from the respirator is facilitated, and oral
feeding is made possible. Swallowing difficulty, which in many cases depends on pharyngeal
and upper esophageal dysfunction, is shown to be linked to aspiration pneumonia.
Furthermore, previous studies indicate that swallowing dysfunction is a frequent problem in
intensive care patients with tracheostomy although the reported incidence varies markedly.
Swallowing function in intensive care patients with tracheostomy is not routinely evaluated
because the current diagnostic techniques, speech pathology bedside assessment (BSA),
fibreoptic endoscopic evaluation of swallowing (FEES), and Videofluoroscopy (VF), are
laborious, subjective expertise-dependent methods. Instead symptoms reported by the patient
during fluid and food intake (cough, chest pain) are allowed to guide further feeding
although it is known that silent aspiration is a common cause for aspiration pneumonia.
To prevent leakage of pharyngeal contents into the trachea most of the tracheostomy tubes
are provided with an air-filled cuff. This cuff, when inflated, exerts pressure against the
inner tracheal wall and thereby seals trachea around the tracheostomy tube. As security this
cuff is often inflated during intake of fluids and food although there are studies that
indicate this may deteriorate swallowing function and in fact increase risk for aspiration.
Automated Impedance Manometry (AIM) analysis is a method that combines measurements of
manometry (pressure) and impedance (flow) using specialized equipment to generate objective
numerical values indicative of the different physiological processes governing safe
pharyngeal swallowing. During a swallow, these measures quantify timing of bolus flow
relative to pharyngeal propulsion, any mechanical resistance to flow during propulsion, and
the overall pharyngeal contractility. Pressure-flow measures are then combined to derive a
swallow risk index (SRI) that provides a global assessment of swallowing and defines a level
of swallowing dysfunction that may predispose to risk of aspiration. This objective
assessment of swallowing function has potential to provide timely and more targeted
treatment options. It is easily conducted at the bedside with minimal disruption of ongoing
medical treatment, and carries with it only negligible risk to the patient. Measures are
derived by using a high resolution impedance manometry (HRIM) system (Sierra Scientific
Instruments, Inc., Los Angeles, California, USA). The system employs a solid state catheter
with 4.2 mm outer diameter incorporating 36 circumferential 1 cm-spaced pressure sensors and
18 2-cm long impedance segments is placed transnasally with sensors straddling the entire
pharyngo- and esophageal segment. Data recordings are done during several bolus swallows and
analysed afterwards using AIM analysis.
Twenty intensive care patients and ten healthy volunteers are included in the study. After
researchers have described the study, participants will be consented, and asked to complete
a brief questionnaire about their swallow function. During the study, participants will be
sitting comfortably in their bed. The manometry catheter will be passed through one nostril
and down into the esophagus, stopping just at the top of the stomach. Once satisfactorily
placed, the participant will be asked to swallow 4 x 5 ml; 4 x 10 ml, 3 x 20 ml of slightly
salty water and 4 x 10 ml semisolid jelly. If first inflated the tracheostomy cuff is now
deflated and the procedure repeated. Furthermore, part of the patients are evaluated by FEES
simultaneously to HRIM measurements. Once the study is completed, the tube is removed.
Patients are followed upp two months after ICU discharge with questionnaire of swallowing
function and also asked to perform an additional HRIM measurement. Volunteers will perform a
similar swallow series as the patients on one study occasion.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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