INTRODUCTION Tracheostomy refers to artificial airway directly into the trachea to the lungs, bypassing the normal pathway (Biau et al., 2019). Literature evidences the impact of tracheostomy tube on voicing and swallowing functions, irrespective of the disease (Jung et al 2012; Terzi et al 2010; Ding & Logemann, 2005). Clinically, it is shown that decannulation of the tracheostomy tube does not automatically restore the laryngeal function. It was observed that the tracheotomised individual are frequently associated with change in voice and aspiration (Macht, 2013; Chaw, Shem, Castillo, Wong & Chang, 2012 ). The frequency of swallowing concerns in tracheostomised individuals could vary from 50 to 83%, depending on method of evaluation (Sharma et al., 2007). The swallowing function is compromised due to the compression of the tracheostomy tube on the oesophagus has also been described to limit swallowing function by either squeezing the esophagus and decreasing the hyolaryngeal movement of the larynx (Bonanno, 1971). Other studies have reported reduced laryngeal excursion especially with inflated cuff (Ding & Logemann, 2005), reduced subglottic pressure, improper coordination between breathing and swallowing in individuals with neurogenic disorders (Terzi et al., 2007) and in individuals diagnosed to have chronic pulmonary diseases (Gross et al., 2009). The risks and the swallowing concerns are heightened among these tracheostomized individuals due to their high medical acuity and due to compromised respiratory status (O’Neil-Pirozzi et al., 2003). Videoflouroscopy Swallow Study (VFSS) is usually a preferred choice of evaluation for objective evaluation of swallowing both in paediatric and adult group (Russo, Lo, Galia et al., 2009; Lo, Galia, Grutta, et al., 2007). It exposes the ingested material through the larynx to the trachea (Robbins et al 1999; Rosenbek et al 1996). It helps in detecting the causes of aspiration (Dodds et al., 1990; Ekburg et al., 1992; Logemann 1999; Harris et al., 2000). Additionally, information on the effect of bolus volumes, textures and compensatory strategies on swallowing mechanism could be observed (Logemann 1999). The video fluoroscopy is more reliable than those obtained with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Oro-pharingo oesophageal scintigraphy (OPES) (Fattori et al., 2016) and is usually considered as gold standard. Furthermore, It reflects on the physiological aspects of pharyngeal phase of swallowing and would be very useful especially when the oral and esophageal phases are affected (Kelly et al 2006; Logemann et al., 1998). The Penetration-Aspiration Scale (PAS) is routinely used scale for quantifying penetration and aspiration during video fluoroscopy (Rosenbek et al., 1996). PAS could be considered as both ordinal and categorical variable (Borders & Brates, 2020). Evidence suggests introducing an appropriate protocol with adequate training reduces the risk of pneumonia (Cichero et al., 2009). Current clinical dysphagia tools used in assessment assess alertness, oral function, posture, voice coughing and a cascade of swallowing events. (Nishiwaki et al, 2005). Currently, Mann Assessment of Swallowing Ability (MASA), Toronto Bedside Swallowing Screening Test (TOR-BSST) are widely used scales in the assessment of dysphagia among the trachestomized individuals. It is important to mention that the TOR-BSST was not assessed for accuracy with patients who were tube-fed or had comorbidities such as reduced level of alertness or pulmonary disease (Martino et al., 2008). The Burke Dysphagia Screening tool had been developed and made available in 1994 (DePippo, Holas, Reding, 1994) but did not meet the published standards. However, these protocols do not comprise of the parameters that needs to be considered in the evaluation of swallowing abilities among the tracheostomised individuals. SUMMARY OF REVIEW OF LITERATURE Based on existing literature, there are studies that have focussed on assessing the swallowing concerns among the tracheostomized individuals using various screening tests, protocols and instrumental evaluation that commonly includes Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofloroscopic Swallow Study (VFSS) in the routine clinical practice. The prevalence of swallowing issues are reported to be high among these individuals due to altered swallowing mechanism. There are several screening tests, protocols used in assessing the swallowing concerns among these individuals. It is also observed that Penetration Aspiration Scale (PAS) is commonly used rating scale in assessing the aspiration risk in instrumental evaluation.
NEED OF THE STUDY Dysphagia is commonly associated in individuals who have undergone tracheostomy. Assessing aspiration in these individuals often require instrumental evaluation which may not be feasible in routine clinical practice. There are limited protocols that are exclusively focussed on assessing the swallowing concerns among these tracheostomised individuals. Hence the present study focusses on validating the developed preliminary protocol using VFSS. AIM & OBJECTIVE OF THE STUDY To validate the Manipal Bedside Swallowing Screening Test (MBSST) for assessing aspiration in individuals with tracheostomy using Video Fluoroscopic Swallow Study (VFSS).
Sample size : Time Bound Study from September 2021 to May 2022 MATERIALS & METHODS a) Inclusion criteria · Individuals with dysphagia post tracheostomy · Individuals above 18 years · Able to sit upright/semi upright posture · Individuals referred for VFSS evaluation b) Exclusion criteria · Individuals who are unable to follow the commands · Individuals with glossectomy INSTRUMENTS USED IN THE STUDY · Manipal Bedside Swallowing Screening Test (MBSST) · Pulse Oximeter · Siemens Axiom Iconos R200 · Video Flouroscopy Swallow Study (VFSS) · Penetration-Aspiration Scale (PAS)
PROCEDURE The study will be carried out after obtaining approval from both Institutional Research Committee (IRC) and Institutional Ethics Committee (IEC) committees. Informed consent will be obtained from the participant or the caregiver. The participants referred for swallowing evaluation fulfilling the selection criteria will be enrolled in the study. The developed protocol will be administered on the participants who are posted for routine barium swallow test. The information pertaining to demographic details, case history and other details will be collected. Followed by this, the participants will be subjected to the preliminary and swallowing assessment. The preliminary assessment includes (14) and swallowing assessment includes (13) domains. The participants will be rated using the protocol on the rating scale and will be scored on the items assessed. The swallowing assessment will be performed across three consistencies. The participant will be seated in upright/semi upright posture. The evaluation will be initiated with liquid consistency (6ml)and the observations will be documented by two speech language pathologist (speech pathologist who is skilled or trained in managing the dysphagia concerns among these individuals). Later the participants would be provided with a trial feed of semi-solid consistency (Vita-Marie biscuit (1/4th part) dipped in 2ML of water and mashed until semi solid consistency is obtained). The observations will be documented. For the solid consistency, the clinician will be providing 1/4th biscuit (Vita-Marie) to the participant, and the observations will be documented as per the domains of the developed protocol. The clinician will be ensuring with standard operating protocol when weaning across consistencies for trial feeds. After the administration of the protocol, the participants will be posted for barium swallow which would be performed by the radiologist. They would be tested across different consistencies similar to the protocol. The feed trials during barium swallow procedure will be carried out in standing position. Microbar® suspension (Barium Sulphate I.P: 95gms, Palatable Base qs: 100ml) will be used during the procedure. The X-Ray will be taken in lateral view at a frame rate of 30 fps. Similar to the protocol, evaluation will initiated with liquid consistency (2 ml water mixed with 4 ml of Microbar® suspension). Later semi-solid consistency trial will be performed (1 quarter of biscuit softened and mashed with 2ml of water and 4 ml of Microbar® suspension). For solid consistency, (1 quarter of biscuit dipped in Microbar® suspension) will be given to the participant. The clinician will make sure that the standard operating protocol is followed when weaning across consistencies for trial feeds to avoid any complications during the procedure. After the completion of all consistencies the images will be viewed and rated using an Penetration Aspiration Scale by a radiologist and speech pathologist.
OUTCOME MEASURES: Scores of the screening test PAS scores DATA ANALYSIS: The data will be analyzed using descriptive statistics. Interrater reliability will be performed between the raters for both screening test and Penetration Aspiration Scale (PAS) . Intra Class Correlation (ICC) will be used to measure the raters agreement. The sensitivity and specificity will be analyzed using (Receiver Operating Characteristic curve (ROC).
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