1. Are Thickened Fluids Worth the Trouble?
A Pilot, RCT of Dysphagia Management
Dr Sue Pownall, Professor Pam Enderby, Professor Tim Hendra, Dr Michelle Marshall 1

2. Exploratory / Pilot Trial
AIM
To undertake a pilot study using a randomised trial design to compare the clinical effectiveness and compliance with two treatment regimes for dysphagia following stroke
The trial was a longitudinal study following the cohort over a twelve week period.

3. Objectives
To investigate whether the treatment intervention of thickening fluids is as good as the treatment intervention of positioning and / or swallowing strategies, in terms of episodes of chest infection, for people experiencing dysphagia following stroke.
To compare the effects of the treatment strategies a) thickening fluids and b) positioning and / or swallowing strategy on fluid intake.
To investigate compliance of patients and carers with each treatment strategy.

4. Method
Cohort of 50 patients admitted into Sheffield Teaching Hospitals with a diagnosis of Stroke
Referred to the SLT Department with a diagnosis of dysphagia
Cohort was selected on a consecutive basis from date of referral.

5. Exclusion Criteria
Patients presenting with moderate or severe receptive dysphasia (as a result of their inability to comply with the treatment instructions necessary if they were randomly assigned to Group B in the study)
Patients were also excluded if they are unable to give informed consent.

6. Randomisation
After initial assessment by the SLT, patients were randomly assigned to one of two treatment groups (A and B)
Group A 16 patients whose dysphagia was managed by using thickened fluids
Group B 16 patients whose dysphagia was managed by postural methods or swallowing strategies.
Group C Cohort of 18 patients, who were deemed as having a safe and efficient swallow for fluids and who were recommended to have normal fluids

7. Intervention Group A Modification to the fluids Normal dense
Coating consistency (Stage 1)
Thick drinking consistency (Stage 2)
Spooning consistency (Stage 3)
National Descriptors
Modification to the fluids

8. Intervention Group B Postural eg chin tuck, head rotation, head turn
Postural and / or swallowing strategies
Postural eg chin tuck, head rotation, head turn
Swallowing Strategies eg supraglottic swallow, Mendelsohn manoeuvre, effortful swallow, super-supraglottic swallow, double swallow

9. Outcomes
Number of episodes of diagnosed chest infection by the medical team over the twelve week intervention period.
Episodes of dehydration.
Compliance of the patient and carers with the treatment strategy using observational techniques by a research assistant.

10. PRIMARY OUTCOME CHEST INFECTION
Defined as the presence of three or more of the following measures, one of which must be ‘b, c, f or g’,
a) Increased temperature >100.5 F (37.4o C)
b) Increased sputum production, colour / quantity
c) Sputum culture
d) Elevated white blood cell count (12x109/litre or above)
e) C-Reactive Protein
f) Auscultatory findings (crepitations or signs of consolidation)
g) X-ray abnormality indicating infection

11. SECONDARY OUTCOME EPISODES OF DEHYDRATION
No one marker of dehydration thus group of markers used, in a similar way to measures used to identify the chest infection measures, to gain content validity.
The agreed markers were:
a) Urea and electrolyte b) Serum sodium c) Osmolarity
Subtle changes across the individual were noted and assumptions made from the whole picture. In order to determine whether an individual patient showed signs of dehydration, consensus was sought from two medical physicians specialising in stroke medicine.

12. Compliance
Patients were observed on a daily basis when taking one drink
Patient and staff were unaware that they were being observed but were aware of the presence of the research assistant at that particular time.
Group A- compliance with the specific thickness of fluid was noted. This was recorded as ‘patient’ compliance if the individual thickened their own drinks or ‘nurse’ compliance if the nurses were thickening the drinks. Patient refusal to have their drinks thickened was also noted.
Group B- Non- compliance was recorded if:
the patient was not using the correct postural / swallowing strategy
For both groups non-compliance was also recorded if:
‘supervision’ by the nursing staff was not given although recommended as part of the intervention by the SLT
patient had not been positioned in an upright posture when this had been recommended

13. Results Population
50 patients were recruited to the study during 7 month period (Sept 2006-March 2007)
31 (62%) of the patients were female and 19 (38%) were male
Age span ranged from 48 – 98 years with a mean of years, median 76.5 years and a mode of 75 years.

14. Results Dysphagia Diagnosis
Group A Group B Group C
Oral stage
Pharyngeal stage
Both
Total
Group A differed significantly from Group C p=0.007
Group A was not significantly different to Group B p=>0.05
Group B was not significantly different to Group C p= >0.05
Two treatment groups were not significantly different in terms of severity for dysphagia

15. Group A Intervention
12 patients were recommended to have coating consistency fluids (Stage 1)
4 were recommended to have thick drinking consistency (Stage 2)
No patients were recommended to have spooning consistency fluids (Stage 3)

16. Group B Intervention Normal fluids plus: Swallow / postural strategy
Number of patients n=16
Chin tuck and small sips 6
Chin tuck only 1
Chin tuck, small sips and head rotation
Chin tuck, small sips and effortful swallow
Chin tuck, small sips and sit bolt upright
Small sips and sit bolt upright
Small sips and supervision
Small sips only
Water only with head rotation and small sips
Water only with double swallow and small sips
Water only, small sips and supervision

17. Group C Intervention
As Group C participants were deemed as not being dysphagic for fluids they were recommended to have normal consistency fluids.

18. Outcomes (chest infection, dehydration and mortality) for 12 week study period for the three groups (N=50) A B C
Total
p value *
Chest Infection
% (n/N)
25% (4/16)
31% (5/16)
28% (5/18)
28% (14/50)
0.925
Dehydration
44% (7/16)
22% (4/18)
32% (16/50)
0.405
Mortality
38% (6/16)
11% (2/18)
24% (12/50)
0.197
*p-value from Chi Square

19. Outcomes (chest infection, dehydration, compliance and mortality) for 12 week study period for the two intervention groups A and B (N=32)

20. Investigative Data
Impact of ability to self feed on the health outcomes
Impact of ability to sit upright on the health outcomes

21. Impact of ability to self feed on the main health outcomes 42 patients (84%) from the total cohort were able to self feed

22. Impact of ability to sit upright on the main health outcomes 29 patients (58%) of the cohort were able to sit upright

23. Conclusions Development of Chest Infection
No evidence of a statistical difference in the development of chest infections between the two treatment groups
If a patient was unable to self feed they were statistically more likely to develop a chest infection
No statistical evidence to show that if a patient was unable to sit upright they are more at risk of developing a chest infection

24. Conclusions Development of Dehydration
No evidence of a statistical difference in the development of dehydration between the two treatment groups
If a patient was unable to self feed they were not at statistically more risk of becoming dehydrated
No statistical evidence to show that if a patient was unable to sit upright they were more at risk of becoming dehydrated

25. Conclusions Compliance
Compliance of patients’ recommended thickened fluids was no worse than for patients recommended the postural / swallowing strategies
Staff were less compliant with the recommendation for thickened fluids than the patients were themselves

26. Final Thoughts
Implementation of either fluid modification or postural/ swallowing strategies, for patients with dysphagia for fluids following stroke may be associated with a reduction in the development of chest infections
The latter strategies in particular, may result in better hydration for the patients
It is difficult to determine the exact contribution of these dysphagia specific interventions as opposed to other aspects of the patient management eg ability to self-feed / adherence to intervention

27. An investigation into the effects of neuro- muscular electrical stimulation (NMES) on swallowing function in patients presenting with persistent dysphagia
Dr Sue Pownall
Sheffield Teaching Hospitals NHS Foundation Trust
This study was jointly funded by:
Devices for Dignity, Sheffield UK and AMPCARE LLC, Texas USA

28. Aspiration – inhaling foreign material
Background
Reduced or delayed hyo-laryngeal elevation is the most common cause of dysphagia & aspiration (Burnett, Mann, Cornell, & Ludlow 2003).
2 Patients Swallowing Under Fluoroscopy (VF)
Compromised
hyo-laryngeal
elevation
Normal hyo-laryngeal elevation
Aspiration – inhaling foreign material
Normal swallow

29. Background
It has been hypothesized that electrical stimulation can assist hyo-laryngeal elevation (Freed et al 2001; Leelamanit et al 2002).
Stimulation of laryngeal elevation musculature via NMES in combination with traditional treatments is suggested to re-educate these muscles when suffering from reduced laryngeal elevation.
Successful swallowing therapy is essential to improve the health status and the quality of life in people with dysphagia.

30. Muscles and Muscle Groups of Interest
Suprahyoid muscle group:
elevate & protract hyoid
Anterior belly
of Digastric
Mylohyoid
Geniohyoid
elevate & retract hyoid
Stylohyoid
Posterior belly

31. NMES Technology
The Rx3ESP® (Effective Swallowing Protocol) utilizes a portable electrical muscle stimulator that works by applying pulsed electrical current through electrodes on the skin to depolarize nerve endings and produce a muscle contraction.
Rx3E Electrodes
Lead wires
Rx3ES Unit
Rx3P (Posture Device)

32. Larynx Larynx with at rest Rx3ESP

33. Purpose
To investigate the effects of NMES of the laryngeal elevation musculature on swallowing function in patients presenting with persistent dysphagia (3 months or greater of non progressive dysphagia status to rule out the variable of spontaneous recovery).
Aim: To increase oral nutrition and hydration by improving swallow function and safety.

34. Inclusion Criteria
Adults with a diagnosis of persistent, non progressive dysphagia (greater than 3 months since diagnosis to rule out the variable of spontaneous recovery) where decreased laryngeal elevation is a key feature of the disorder, diagnosed by videofluoroscopy examination.

35. Exclusion Criteria
Adults who had an implanted electronic device e.g. Pacemaker.
Adults presenting with moderate or severe receptive aphasia (a language disorder occurring as a result of CVA), and/or cognitive impairment. These people were excluded as a result of the increased likelihood of their inability to comply with the treatment instructions.
Patients who were unable to give informed consent.
Patients presenting with progressive diseases.
Patients who were pregnant.
Patients who had active cancerous lesions or infections which were present in the treatment area.

36. Method
8 Sheffield SLT’s were trained in the principles of NMES and the use of the Rx3ESP
Feasibility study using a case series which included 5 patients with stable and persistent dysphagia who presented with decreased laryngeal elevation diagnosed by Videofluoroscopy (VF).
Participants received 4 weeks of daily intervention (5 days per week for 30 minutes based on the Rx3ESP). Participant’s swallowing was re-assessed by VF and clinical assessment post intervention. A follow-up assessment was completed two weeks after completion of the intervention.

37. Method
The ethical committee giving consent for the study had requested that those patients who wanted to continue with the intervention after the 4 weeks study period should be offered further intervention if possible.
Patients 2, 3, and 4 continued with the intervention for an added 2 weeks with the intervention three times per week. These patients underwent a further VF procedure one week later.
Patients 1 and 5 were followed up 2 weeks after completion in the study (without further intervention or further VF) to gain qualitative data on their progress.

38. Procedure
Initially the intensity of current was slowly increased to maximum tolerance, according to patients feedback. Maximum tolerance was defined as the level of motor contraction of the muscles reported as a “grabbing” sensation by the patient without being painful.

39. Procedure
To lessen the chance of current accommodation the SLT’s were instructed to ask the patient two times during the course of each session if they could tolerate more intensity (i.e. after the initial 10 minutes and 20 minutes of the 30 minute session).
Patients were asked to perform the following 3 exercises for 10 minutes each during stimulation “on” times:
Modified Shaker into the Rx3P for 4 seconds followed by a swallow.
Mendelsohn Maneuver for 4 seconds followed by a swallow.
Effortful Swallow.

40. Procedure Exercise and NMES Duty Cycle Progression
Week 1 – Duty cycle will be 5 seconds on and 25 seconds off for a total of 60 stimulations (i.e. 20 Shaker, 20 Mendelsohn, 20 Effortful)
Week 2 – Duty cycle will be 5 seconds on and 20 seconds off for a total of 72 stimulations
(i.e. 24 Shaker, 24 Mendelsohn, 24 Effortful)
Week 3-4 – Duty cycle will be 5 seconds on and 15 seconds off for a total of 90 stimulations
(i.e. 30 Shaker, 30 Mendelsohn, 30 Effortful)

41. Outcome Measures Data was collected using the:
Functional Oral Intake Scale (FOIS)
Rosenbek Penetration/aspiration scale
Waxman Dysphagia severity scale
Patients also completed a questionnaire about their experiences and the acceptability of the intervention.
SLT’s attended a group interview to discuss the use of the device and protocol.
Data was analyzed using descriptive statistics under the guidance of a medical statistician.

42. Results 5 patients were recruited to the study during June of 2011.
All were male and ages ranged from years.
All patients were PEG dependent and the length of persistent dysphagia ranged from 3 months to two years.
All participants completed 20 sessions, described the intervention as acceptable and would strongly recommend it to others.
Patient
Diagnosis
Age 1
CVA Right PICA February 2011 69 2
Tonsillar Cancer Neck Dissection Left Side 2009 59 3
CVA Right MCA 2009 78 4
Right Glomus Jugular Tumor 2009 71 5
Left Skull Base Osteomyelitis with Left Vocal Cord Palsy 2009 65

43. Results
All 5 participants showed improvements in their swallowing to varying degrees.
2 participants returned to full oral diet having been on non-oral feeding for 5 months and over 24 months respectively, although one continued to show aspiration with some intake. Both ceased nutritional intake via PEG reducing costs to the NHS.
3 patients introduced an increased amount and range of food consistencies to their oral intake, although they continue to receive their main nutrition via PEG.

44. Rosenbek Penetration/Aspiration Scale Liquids
Post 4 week intervention
The two patients with a diagnosis of Stroke showed improvements in the levels of aspiration/penetration occurring during liquid swallows (Patients 1 & 3)
Patient 4 showed a worse score with liquids however on the post intervention VF he was feeling unwell and by the follow-up he was taking larger sips on the follow-up VF. Scores with these ranged from 1-7 so amount of aspiration is variable.

45. Rosenbek Penetration/Aspiration Scale Solids
Post 4 week intervention
Two patients who were deemed from clinical decisions to be unsafe to try solid diet on the first VF examination went on to swallow these on the post intervention VF (Patients 2, & 5).
Follow-up
Patient 2 showed an improvement in penetration levels with both liquid and solid swallows
Patient 4 was assessed with solid which had been deemed from clinical decision at the first two VFs to be unsafe.

46. Results Patient description of daily oral intake
Patient 1 - Pre - 5 teaspoons fluid or 5 teaspoons soft fork mashed diet at any one sitting.
Post - Sips fluid and small amounts soft diet.
Follow-up - Eating full oral intake. PEG to be removed. 
Patient 2 - Pre - Half pint soup taken in small amounts throughout day.
Post - As above plus half a cup of coffee. Sometimes able to drink a whole cup in one sitting.
Follow-up - As above plus 4x half cup coffee per day. Introducing small amount soft fork mashable
foods.
Patient 3 - Pre - small amounts normal diet and fluids.
Post - increased amount of oral intake. PEG feed has been reduced to 1 litre from 2 litres intake.
Follow-up - Full oral intake. Flushing PEG only to keep patent.
Patient 4 - Pre cups tea per day.
Post - as above but easier to swallow and less coughing occurring
Follow-up - intermittently eating minimal amounts soft fork mashed diet. First solid food in 3 years.
Patient 5 - Pre- Water only sucked from mouth sponges.
Post- Sips water, plus small amount soft fork mashed diet
Follow-up- as above

47. Conclusion
Results suggest this technique may be an effective intervention for some patients presenting with persistent dysphagia.
A pilot study is now planned to investigate the technique using a randomized design.

48. References
Burnett TA, Mann EA, Cornell SA & Ludlow CL. Laryngeal Elevation Achieved by Neuromuscular Stimulation at Rest. J Appl Physiol., 94: , 2003.
Freed ML, Freed L, Chatburn RL & Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care 46 (5): ,
Leelamanit V, Limsakul C & Geater A. Synchronized electrical stimulation in treating pharyngeal dysphagia. Laryngoscope 112(12): ,
Mueller MJ & Maluf KS. Tissue Adaptation to Physical Stress: A Proposed "Physical Stress Theory" to guide physical therapist practice, education, and research. Physical Therapy, 82(4): 383 – 403, 2002.
Rosenbek JC, Robbins JA, Roecker EB, Coyle JL & Wood JL. A penetration-aspiration scale. Dysphagia, Spring; 11(2): 93-8, 1996.