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DysphagiaNCT02874352

Incidence of Dysphagia in Intensive Care Patients With Tracheostomy

A study testing high resolution impedance manometry with Automated Impedance Manometry analysis in people with Dysphagia and Oropharyngeal Dysphagia, run by Region Örebro County.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will inform the feasibility of the High Resolution Impedance Manometry (HRIM) system combined with Automated Impedance Manometry (AIM) analysis as a screening tool for dysphagia and aspiration for the intensive care population with tracheostomy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dysphagia, Oropharyngeal Dysphagia
What is being tested?
high resolution impedance manometry with Automated Impedance Manometry analysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Oct 2016to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Intensive care patient with tracheostomy ( applies only to patients)
  • Age > 18 years
  • Ability to sit upright and to swallow on command as well as to swallow thin liquids
  • Informed and signed consent

Who cannot join

  • Pre-existing dysphagia
  • History of upper gastrointestinal surgery
  • Current medication known to affect esophageal motility
  • Pregnancy
  • Severe coagulopathy
  • Allergy to local anaesthetics

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Incidence of Dysphagia in Intensive Care Patients With Tracheostomy Using High Resolution Pharyngoesophageal Manometry and Impedance

This study will inform the feasibility of the High Resolution Impedance Manometry (HRIM) system combined with Automated Impedance Manometry (AIM) analysis as a screening tool for dysphagia and aspiration for the intensive care population with tracheostomy. This pilot study aims to determine the incidence of dysphagia and aspiration risk in intensive care patients with tracheostomy and the investigators hypothesise that the incidence of dysphagia in intensive care patients with tracheostomy will be higher than in an age matched population.

Read the detailed description

Aspiration pneumonia is a common mechanism for recurrent mechanical ventilation episodes in intensive care patients and leads to longer hospital admissions, increased morbidity, and mortality. When length of the mechanical ventilation is prolonged the translaryngeal tube is changed to a tracheostomy tube. This practice has several advantages: further pressure damage to the vocal cords is avoided, weaning from the respirator is facilitated, and oral feeding is made possible. Swallowing difficulty, which in many cases depends on pharyngeal and upper esophageal dysfunction, is shown to be linked to aspiration pneumonia. Furthermore, previous studies indicate that swallowing dysfunction is a frequent problem in intensive care patients with tracheostomy although the reported incidence varies markedly.

Swallowing function in intensive care patients with tracheostomy is not routinely evaluated because the current diagnostic techniques, speech pathology bedside assessment (BSA), fibreoptic endoscopic evaluation of swallowing (FEES), and Videofluoroscopy (VF), are laborious, subjective expertise-dependent methods. Instead symptoms reported by the patient during fluid and food intake (cough, chest pain) are allowed to guide further feeding although it is known that silent aspiration is a common cause for aspiration pneumonia.

To prevent leakage of pharyngeal contents into the trachea most of the tracheostomy tubes are provided with an air-filled cuff. This cuff, when inflated, exerts pressure against the inner tracheal wall and thereby seals trachea around the tracheostomy tube. As security this cuff is often inflated during intake of fluids and food although there are studies that indicate this may deteriorate swallowing function and in fact increase risk for aspiration.

Automated Impedance Manometry (AIM) analysis is a method that combines measurements of manometry (pressure) and impedance (flow) using specialized equipment to generate objective numerical values indicative of the different physiological processes governing safe pharyngeal swallowing. During a swallow, these measures quantify timing of bolus flow relative to pharyngeal propulsion, any mechanical resistance to flow during propulsion, and the overall pharyngeal contractility. Pressure-flow measures are then combined to derive a swallow risk index (SRI) that provides a global assessment of swallowing and defines a level of swallowing dysfunction that may predispose to risk of aspiration. This objective assessment of swallowing function has potential to provide timely and more targeted treatment options. It is easily conducted at the bedside with minimal disruption of ongoing medical treatment, and carries with it only negligible risk to the patient. Measures are derived by using a high resolution impedance manometry (HRIM) system (Sierra Scientific Instruments, Inc., Los Angeles, California, USA). The system employs a solid state catheter with 4.2 mm outer diameter incorporating 36 circumferential 1 cm-spaced pressure sensors and 18 2-cm long impedance segments is placed transnasally with sensors straddling the entire pharyngo- and esophageal segment. Data recordings are done during several bolus swallows and analysed afterwards using AIM analysis.

Twenty intensive care patients and ten healthy volunteers are included in the study. After researchers have described the study, participants will be consented, and asked to complete a brief questionnaire about their swallow function. During the study, participants will be sitting comfortably in their bed. The manometry catheter will be passed through one nostril and down into the esophagus, stopping just at the top of the stomach. Once satisfactorily placed, the participant will be asked to swallow 4 x 5 ml; 4 x 10 ml, 3 x 20 ml of slightly salty water and 4 x 10 ml semisolid jelly. If first inflated the tracheostomy cuff is now deflated and the procedure repeated. Furthermore, part of the patients are evaluated by FEES simultaneously to HRIM measurements. Once the study is completed, the tube is removed. Patients are followed upp two months after ICU discharge with questionnaire of swallowing function and also asked to perform an additional HRIM measurement. Volunteers will perform a similar swallow series as the patients on one study occasion.

Being tested
high resolution impedance manometry with Automated Impedance Manometry analysis
Keywords
intensive care, tracheostomy
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high resolution impedance manometry with Automated Impedance Manometry analysisDevice

Study groups in NCT02874352
Study groupRoleWhat they receive
intensive care patientsOtherintensive care patients with tracheostomy/ high resolution impedance manometry with Automated Impedance Manometry analysis
Receives: Device: high resolution impedance manometry with Automated Impedance Manometry analysis
healthy volunteersOthercontrol group with healthy volunteers/ high resolution impedance manometry with Automated Impedance Manometry analysis
Receives: Device: high resolution impedance manometry with Automated Impedance Manometry analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure Flow Measurements

    Pressure Flow measurements generated by HRIM registrations and analysed by AIM analysis

    Measured: 1 hour

Secondary outcomes (2)
  1. Sydney Swallow Questionaire (SSQ)

    Clinical swallow assessment

    Measured: 1 hour

  2. Functional Oral Intake Scale (FOIS)

    Clinical swallow assessment

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874352
Sponsor's protocol ID
JS005
Status last verified
Aug 2016
First submitted
17 Aug 2016
Last updated
23 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing high resolution impedance manometry with Automated Impedance Manometry analysis in people with Dysphagia and Oropharyngeal Dysphagia, run by Region Örebro County.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johanna Savilampi (+46 019 6020266, johanna.savilampi@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Flow Measurements (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.

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