A study with patients who have swallowing difficulties and are artificially ventilated with a direct access tube to assess the benefit of using the Phagenyx device for early removal of the direct access tube

• Register: ISRCTN
• Last refreshed on: 24 September 2018
• Main ID: ISRCTN18137204
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Phagenesis Limited
• Public title: A study with patients who have swallowing difficulties and are artificially ventilated with a direct access tube to assess the benefit of using the Phagenyx device for early removal of the direct access tube
• Scientific title: Benefit of PHAryngeal electrical STimulation for early de-cannulation in TRACheotomised stroke patients with neurogenic dysphagia : a prospective randomized single-blinded interventional study (PHAST TRAC study)
• Date of first enrolment: 01/04/2015
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN18137204
• Study type: Interventional
• Study design: Randomised single-blind interventional study (Quality of life)

Countries of recruitment

Austria, Germany, Italy

Contacts

• Name: Satish Mistry

Key inclusion & exclusion criteria

Inclusion criteria: 1. Haemorrhagic or ischaemic stroke
2. Supratentorial
3. Mechanically ventilated for a minimum of 48 hours after the stroke event
4. Tracheotomised for any reason
5. Weaned from mechanical ventilation
6. Not taking sedatives for a minimum of 3 days
7. Ineligible for decannulation for a minimum of 10 days after the stroke event
8. Ineligible for decannulation for a minimum of 24 hours and a maximum of 72 hours after the first decannulation assessment
9. Cannot receive oral food (DSRS=12 and FOIS = 1)
10. Richmond Agitation and Sedation Scale > – 1
11. > 18 years old
12. Voluntary written informed consent provided by patients or their legal relatives/authorities
Exclusion criteria: Current exclusion criteria as of 27/07/2015:
1. Undefined date of stroke causing the dysphagia (but not excluded stroke occurring during the night, for which the date will be the morning the stroke was observed)
2. Pre-existing dysphagia
3. Infratentorial stroke
4. Pre-existing neurogenic dysphagia or a disease linked to this symptom (e.g., Parkinson disorder)
5. Non-neurogenic dysphagia (e.g., cancer)
6. Neuromuscular disorders (e.g., myasthenia gravis or motor neurone disease)
7. Participating in any other study (of a medicine or medical device) that might affect the outcome of PES, and for which the patient signed a consent form
8. Receiving or have received within 1 month before the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia
9. Have a pacemaker or an implantable defibrillator
10. Have a nasal anatomical deformity, nasal airway obstruction, have had oesophageal surgery or any other circumstance where placement of a standard NG feeding tube would be deemed unsafe
11. Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe
12. Receive oxygen therapy whilst the oxygen supply is in place or in operation
13. Pregnant or nursing women
14. Requiring emergency treatment that prevents the appropriate informed consent process
15. Life expectancy less than the duration of the patient’s follow-up (i.e., < 3 months)

Previous exclusion criteria:
1. Undefined date of stroke causing the dysphagia (but not excluded stroke occurring during the night, for which the date will be the morning the stroke was observed)
2. Pre-existing dysphagia
3. Infratentorial stroke
4. Pre-existing neurogenic dysphagia or a disease linked to this symptom (e.g., Parkinson disorder)
5. Non-neurogenic dysphagia (e.g., cancer)
6. Neuromuscular disorders (e.g., myasthenia gravis or motor neurone disease)
7. Participating in any other study (of a medicine or medical device) that might affect the outcome of PES, and for which the patient signed a consent form
8. Receiving or have received within 1 month before the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia
9. Cardiac pacemaker or cardioverter defibrillator, unless device can be switched off completely at the time of treatment
10. Oesophageal perforation, oesophageal stricture or pouch
11. Unstable cardiopulmonary status
12. Severe pneumonia that cannot be stabilised by medication and prevents decannulation
13. Receiving continuous oxygen treatment or having equipment for such treatment permanently in place, preventing the positioning of the Phagenyx catheter (does not exclude patients who are intubated or have a tracheotomy in which an inflated balloon creates a firm barrier between the space where oxygen might be present (trachea/lungs) and the space where the electrical stimuli are delivered (oropharynx), or patients who can have the oxygen treatment temporarily stopped and equipment removed during PES treatment)
14. Pregnant or nursing women
15. Requiring emergency treatment that prevents the appropriate informed consent process
16. Life expectancy less than the duration of the patient’s follow-up (i.e., < 3 months)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Patients after supratentorial stroke with neurogenic dysphagia who need mechanical ventilation support initially but are weaned from this support and who are tracheotomised thereafter to reduce potential complications, but the tracheal tube cannot be removed due to ongoing swallowing problems and risks for penetration and aspiration of saliva
Nervous System Diseases
Neurogenic dysphagia

Intervention(s)

1. CE-marked Phagenyx Base Station (EPS1) and Phagenyx catheter are commercially available for the treatment of neurogenic dysphagia and apply a standard electrical stimulation treatment at 5 Hz via the Phagenyx catheter, which is essentially a standard nasogastric feeding tube provided with built-in stimulation electrodes. The intensity of stimulation is optimised for each treatment by the Base Station software and operator input by setting the intensity at 75% of the tolerable limit above sensory threshold. The catheter houses an integrated circuit that allows the application of the 10 minute electrical stimulation therapy three times (i.e., during 3 consecutive days).
2. Removal of the tracheotomy tube will be attempted at the same timepoint after randomisation for patients in both the early and late PES treatment groups.
3. Patients in the early group will receive the standard PES treatment delivered by the Phagenyx device immediately (0–24 hours) after randomisation.
4. If the tube cannot be removed successfully, patients in the early treatment group will receive a second standard PES treatment and patients in the late treatment group will be given their first standard PES treatment. Removal of the tracheotomy tube will be attempted again after this standard PES treatment.

Primary Outcome(s)

1. Proportion of patients in the early treatment group who can be decannulated* after the first exposure to standard PES treatment
2. Proportion of patients in the late treatment group who can be decannulated* at a similar timepoint without exposure to the standard PES treatment
Decannulation success measured at 3-5 days post Day 0 (randomisation) with Warnecke et al. 2013 decannulation protocol.

Added 27/07/2015:
*Cuff deflation is considered as decannulation

Secondary Outcome(s)

Current secondary outcome measures as of 10/11/2015:
1. Severity of dysphagia after PES treatment measured at Day 0 (randomisation), each decannulation attempt, every 48 hours for first 10 days, every 5 days after day 10 up to day 30 and at 3 months, measured with standard assessment scales (Dysphagia Severity Rating Scale [DSRS] and Functional Oral Intake Scale [FOIS]) and comparison with baseline
2. Success rates of decannulation in the late treatment group of the study after exposure to the standard PES treatment
3. Success rates of decannulation in the early treatment group of the study after a second exposure to the standard PES treatment
4. Treatment optimisation parameters (threshold, tolerance and intensity of the electrical stimulation)
5. Severity of the stroke measured using the standard NIHSS and modified Ranking Scale (mRS) at different time points after the PES treatment during the 30-day follow-up period and for mRS at the 3-month timepoint

Previous secondary outcome measures:
1. Severity of dysphagia after PES treatment measured at Day 0 (randomisation), each decannulation attempt, every 48 hours for first 10 days, every 5 days after day 10 up to day 30 and at 3 months, measured with standard assessment scales (Dysphagia Severity Rating Scale [DSRS] and Functional Oral Intake Scale [FOIS]) and comparison with baseline
2. Success rates of decannulation in the late treatment group of the study after exposure to the standard PES treatment
3. Success rates of decannulation in the early treatment group of the study after a second exposure to the standard PES treatment
4. Treatment optimisation parameters (threshold, tolerance and intensity of the electrical stimulation)
5. Severity of the stroke, measured with the standard National Institutes of Health Stroke Scale and modified Ranking Scale at Day 0 (randomisation), day 10 and every 5 days up to days 30, and at 3 months

Secondary ID(s)

AHE03; EUDRMED Number: CIV-15-02-013145

Source(s) of Monetary Support

Phagenesis Limited (UK)

Ethics review

Status:
Approval date:
Contact:

Germany: 1. Ethik Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultat der Westfälischen Wilhelms-Universisät, 31/03/2015, ref: 2015-081-f-M 2. Ethik Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultat der Westfälischen Wilhelms-Universisät, 06/08/2015, ref: 2015-081-f-M, 3. Ethik Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultat der Westfälischen Wilhelms-Universisät, 02/11/2015, ref: 2015-081.f-M 4. Ethik Kommission der Ärzteka

Results

• Results available: Yes
• Date Completed: 05/07/2017