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

Completed

• Conditions: 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

• Registration Number: ISRCTN18137204
• Lead Sponsor: Phagenesis Limited

Brief Summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27807279 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30170898

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-23
• Study Completion: 2017-07-05
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of patients in the early treatment group who can be decannulated* after the first exposure to standard PES treatment <br>2. Proportion of patients in the late treatment group who can be decannulated* at a similar timepoint without exposure to the standard PES treatment<br>Decannulation success measured at 3-5 days post Day 0 (randomisation) with Warnecke et al. 2013 decannulation protocol.<br><br>Added 27/07/2015:<br>*Cuff deflation is considered as decannulation