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CTRI Number  CTRI/2019/07/020418 [Registered on: 29/07/2019] Trial Registered Prospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Comparing the oxygen levels and swallowing sounds for liquids and semisolids in individuals with stroke  
Scientific Title of Study   Comparison of liquid and semisolid consistency in the evaluation of dysphagia using cervical auscultation and pulse oximetry in post stroke individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepa N Devadiga 
Designation  Associate Professor 
Affiliation  Manipal College Of Health Professions 
Address  Department of speech and hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986447191  
Fax    
Email  deepkmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepa N Devadiga 
Designation  Associate Professor 
Affiliation  Manipal College Of Health Professions 
Address  Department of speech and hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986447191  
Fax    
Email  deepkmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepthi crasta 
Designation  Post Graduate student 
Affiliation  Manipal College Of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9611104597  
Fax    
Email  deepthicrasta108@gmail.com  
 
Source of Monetary or Material Support  
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Applied for Indian Council of Social Science Research ICSSR 
Address  Indian Council of Social Science Research (ICSSR) Ministry of Human Resource Development JNU Institutional Area, Aruna Asaf Ali Marg, New Delhi- 110067  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE  NOT APPLICABLE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepa N Devadiga  KMC Hospital   Department of Neurology
Udupi
KARNATAKA 
9986447191

deepkmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cervical auscultation and Pulse oximetry  Cervical auscultation is used to assess the pharyngeal phase of swallowing by listening to the sounds of swallowing and respiration during the process of swallowing. Pulse oximetry provides accurate measurement of SpO2 variations during swallowing 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  41.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
Individuals with episode of stroke with GCS>8
Individuals who are on enteral/parenteral feeding
Level of Alertness – Must be able to respond to verbal stimuli
Clearance from the treating Physician
 
 
ExclusionCriteria 
Details  Exclusion criteria:
Unable to follow instructions (Aphasia/Cognitive problems/ Hearing loss/Other
Associated conditions)
Tracheostomy/ Ventilator/ GCS less than 8 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome measures for cervical auscultation include duration, amplitude, frequency and wave
morphology
and Outcome measures for Pulse oximetry include baseline SPO2 level, during SPO2 level and post feed SPO2 level
 
Data collection and Data Analysis: From July 2019 to March 2020
 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Introduction
Dysphagia refers to swallowing difficulty and can be a symptom that is concomitant with other medical conditions that includes stroke, head and neck cancer, gastroesophageal reflux,
oesophageal disorders and or other systemic diseases. It is defined as difficulty in transporting saliva, liquid, or food from the oral cavity to the stomach (Tjaden, 2008). It is commonly seen
among the individuals who suffer from neurological disorder across all the age groups. (Calis et al., 2008; Martino et al., 2005). Dysphagia can manifest itself through symptoms like aspiration,
penetration, oral residue, regurgitation of liquids or solids ( Logemann, 1998) and can lead to life threatening conditions like malnutrition, dehydration, and aspiration pneumonia (Katzan, Cebul,
Husak , Dawson, & Baker, 2003). Hence a comprehensive evaluation would be essential in order to avoid the secondary complications associated with dysphagia.
The swallowing assessment is usually done using the bedside clinical swallowing evaluation reflecting only on oral phase of swallowing in most of the clinical set up. Beside the routine clinical
practice, instrumental examination is also used to assess other phases of swallowing in case of suspected dysphagia based alone with CSE. The VFSS and FEES are two widely used instrumental
methods till date (Madden, Fenton, Hughes, & Timon, 2000). Although these methods are widely used in the evaluation of dysphagia, they still persist with pros and cons. VFSS is an invasive
procedure with radiation exposure and cannot be performed on all, and aspiration being variable, it only reflects one time measure. FEES only allows for the inspection of velopharyngeal,
oropharyngeal, pharyngeal, and laryngeal functions, it does not permit any systematic evaluation of oral or esophageal components of swallowing. It is not widely available and requires skilled
personnel. (Madden et al., 2000).
During the acute period of stroke, decisions on weaning to oral feed must be based on reliable bedside evaluation. Literature over the past few years has been investigating the consistency and
strength of dysphagia screening and assessment tools. Cervical auscultation and pulse oximetry are two such tools which are being widely studied for dysphagia assessment and management.
They are being adopted in the routine clinical practice for detecting dysphagia. Cervical auscultation is used to assess the pharyngeal phase of swallowing by listening to the sounds of
swallowing and respiration during the process of swallowing. It is used to evaluate the coordination between swallowing and respiration, and to distinguish between pathological and a normal
swallow (Leslie, Drinnan, Finn, Ford, & Wilson, 2004). Recent studies also reflect on considering the pulse oximetry (PO) in identifying the signs and management of dysphagia (Rogers, Arvedson, Msall, & Demerath, 1993; Rogers, Msall, & Shucard, 1993; Zaidi et al., 1995). It is a means of providing accurate measurement of SpO2 which can ascertain variations in SpO2. Similar to cervical auscultation, the pulse oximetry is objective, noninvasive which provides constant readings that can be saved and further analysed. The
assessment and management of dysphagia seeks for a multidisciplinary approach and repeated assessments during rehabilitation (Gandolfi et al., 2014). This would be possible only if the tools
adopted are easily accessible, inexpensive, less time consuming, feasible and avoid discomfort to the individual.

Review of literature:
Literature over the past few years has been investigating the dependability and rationality of dysphagia assessment tools. Cervical auscultation and pulse oximetry are two such tools which are being widely studied for dysphagia assessment and management. They are being adopted in the routine clinical practice for detecting dysphagia. CA is developing as an area of interest for the study of dysphagia in adults, children, and infants. It is easy to use, inexpensive, and non-invasive (Greif & loughlin, 1996). The extent of its utility in evaluating the pharyngeal phase and aiding to diagnosis is a matter of debate in both research and clinical setting. Irrespective of its uncertainty, it is still considered as a useful tool in clinical evaluation, together with other methods for the speech language therapist in the assessment of dysphagia (Ferrucci, Mangilli, Sassi, Limongi, and Andrade, 2013). Zenner, Losinski, and Mills (1995) were the first ones to study cervical auscultation. They compared the reliability and validity of the cervical auscultation to that of videofluoroscopy in 50 male participants who were referred for suspected dysphagia. Overall, the study suggested that it is unclear how aspiration can be identified using cervical auscultation in the clinical swallowing assessment. Leslie et al. (2004) examined if SLPs experienced in cervical auscultation could identify aspiration by swallowing sounds alone. The results of the study evidenced that cervical auscultation can be considered as a reliable tool to identify aspiration to some extent. Santamato et al. (2009) analysed the swallowing sounds acoustically, using a microphone and computer, in healthy and individuals with dysphagia secondary to neurological diseases. The mean duration of the swallowing sounds and post swallowing apnoea were recorded. Penetration/aspiration was verified by FEES in all individuals with dysphagia. The mean duration of swallowing sounds for a liquid bolus of 10 ml water was significantly different between individuals with dysphagia and healthy participants.
Pulse oximetry provides instant information during bedside evaluation, which may be useful for recommendations regarding further investigation and feeding. The potential use of pulse oximetry as a tool for the assessment of dysphagia has been well documented. Sherman, Nisenboum, Jesberger, Morrow, and Jeberger (1999) assessed 46 participants using pulse oximetry and videofluoroscopy and found that participants who exhibited laryngeal penetration and/or aspiration without clearing (i.e. coughing) demonstrated significant drop in SpO2 level. Conversely, who penetrated and cleared or did not demonstrate penetration did not exhibit this decline. The authors suggested that with further investigation, it might be possible to identify threshold level to allow the use of pulse oximetry in routine assessment. Smith et al. (2000) compared pulse oximetry to bedside assessment and videofluoroscopy in a study of 53 patients following acute stroke. They found that combining the bedside assessment with pulse oximetry gave the best positive predictive value of 95% (with penetration +/- aspiration as end point).

Purpose:

The purpose of the trial is mainly to add objectivity in routine bedside swallowing evaluation. The detection of aspiration at bedside swallowing examination is complex without objective tools tending to either over diagnose or under diagnose aspiration. The objective methods like Videofluroscopy and FEES are invasive, expensive and time consuming, and may not be easily performed on all individuals. Hence it is necessary to focus on incorporating simple, non-invasive evaluation methods that can be used along with bedside evaluation on a routine basis.

Clinical experiences have revealed abnormal findings in SpO2 especially in brain stem stroke individuals. Despite the extensive research on SPO2 changes during swallowing and comparison of swallow acoustics across bolus consistencies, with mixed findings there has been limited focus on the same in the Indian context. Hence the present study attempts to explore the feasibility of pulse oximetry with cervical auscultation in routine bedside swallowing evaluation of post stroke individuals. 

Aim:
To compare the liquid and semisolid consistency in the evaluation of Dysphagia using cervical
auscultation and pulse oximetry in post stroke individuals.

Objectives:
To compare the swallowing across liquid and semisolid consistency using cervical
auscultation acoustically

To compare the oxygen saturation levels at baseline, during and post feed between
consistencies
Method:
This study would commence after obtaining the approvals from Institutional Research Committee (IRC) and Institutional Ethics Committee (IEC). Informed consent will be obtained from all the participants/family members.
Study setting: The study will be conducted in the premises of Kasturba Hospital, Manipal.
Proposed study design: A cross sectional research design
Sampling method: Convenience sampling will be used.
Participants: A total of N = 32 participants post stroke in the age range of 41-70 years will be enrolled in the study.
Inclusion criteria: 
  •  Individuals with episode of stroke with GCS>8
  •  Individuals who are on enteral/parenteral feeding 
  • Level of Alertness – Must be able to respond to verbal stimuli 
  •  Clearance from the treating Physician 
Exclusion criteria: 
  •  Unable to follow instructions (Aphasia/Cognitive problems/ Hearing loss/Other Associated conditions) 
  •  Tracheostomy/ Ventilator/ GCS less than 8

Procedure: 
All participants recruited will receive stroke specific evaluation by the neurologist and Dysphagia specific evaluation by the speech pathologist. The other findings (demographic, medical, associated problems and other significant history if any) will be documented using a proforma by the speech pathologist. A preliminary swallowing examination will be initiated using the routine clinical swallowing examination. Following, the feed trial will be initiated only if the participant is alert, conscious and able to follow commands. The participant will be made to sit in upright/ semi upright posture. The participant will be explained regarding the procedure. The feed trial will be initiated with water swallow test. The pulse oximeter will be clipped to the participant. The participant will be instructed to sip 5ml of water and will be asked to swallow it once the command is given. As the participant swallows, the SpO2 level will be monitored at baseline/ during/ and post feed. The cervical auscultation will be performed using the electronic stethoscope, placed on antero-lateral aspect of laryngeal region during the swallowing. The stethoscope will be connected to the software and the swallowing sound will be recorded. If the participant exhibits overt signs of aspiration (continuous episodes of cough, watery eyes), the procedure will be terminated. If the participants exhibits no difficulty (overt signs), the procedure will be repeated for semisolid consistency (5ml), only if the clearance of oral hygiene will be rated as fair or good on a 3 point rating scale within a duration of 30mins of the liquid feed trial. The cervical auscultation will be analysed for duration, amplitude, frequency and morphology of waveform. The participant will be monitored throughout for any overt or covert signs of aspiration. 

Outcome measures:
Outcome measures for cervical auscultation includes duration, amplitude, frequency and wave morphology and pulse oximetry includes oxygen saturation levels before, during and post feed.

Benefits:The potential benefit will include preventing the participants from undergoing unnecessary, tiring,
expensive and cumbersome procedures to an extent, as the protocol will serve as a preliminary
indicator towards other investigations. It would also aid in facilitating from tube feed to oral feed
systematically.
 
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