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Incidence of Dysphagia in Intensive Care Patients With Tracheostomy

Primary Purpose

Dysphagia, Oropharyngeal Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high resolution impedance manometry with Automated Impedance Manometry analysis
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysphagia focused on measuring intensive care, tracheostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    intensive care patients

    healthy volunteers

    Arm Description

    intensive care patients with tracheostomy/ high resolution impedance manometry with Automated Impedance Manometry analysis

    control group with healthy volunteers/ high resolution impedance manometry with Automated Impedance Manometry analysis

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Sydney Swallow Questionaire (SSQ)
    Clinical swallow assessment
    Functional Oral Intake Scale (FOIS)
    Clinical swallow assessment

    Full Information

    First Posted
    August 17, 2016
    Last Updated
    August 22, 2016
    Sponsor
    Region Örebro County
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02874352
    Brief Title
    Incidence of Dysphagia in Intensive Care Patients With Tracheostomy
    Official Title
    Incidence of Dysphagia in Intensive Care Patients With Tracheostomy Using High Resolution Pharyngoesophageal Manometry and Impedance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    May 2018 (Anticipated)
    Study Completion Date
    September 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Örebro County

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia, Oropharyngeal Dysphagia
    Keywords
    intensive care, tracheostomy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intensive care patients
    Arm Type
    Other
    Arm Description
    intensive care patients with tracheostomy/ high resolution impedance manometry with Automated Impedance Manometry analysis
    Arm Title
    healthy volunteers
    Arm Type
    Other
    Arm Description
    control group with healthy volunteers/ high resolution impedance manometry with Automated Impedance Manometry analysis
    Intervention Type
    Device
    Intervention Name(s)
    high resolution impedance manometry with Automated Impedance Manometry analysis
    Primary Outcome Measure Information:
    Title
    Pressure Flow Measurements
    Description
    Pressure Flow measurements generated by HRIM registrations and analysed by AIM analysis
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Sydney Swallow Questionaire (SSQ)
    Description
    Clinical swallow assessment
    Time Frame
    1 hour
    Title
    Functional Oral Intake Scale (FOIS)
    Description
    Clinical swallow assessment
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Pre-existing dysphagia History of upper gastrointestinal surgery Current medication known to affect esophageal motility Pregnancy Severe coagulopathy Allergy to local anaesthetics
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Johanna Savilampi
    Phone
    +46 019 6020266
    Email
    johanna.savilampi@regionorebrolan.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Per Cajander
    Phone
    +46 019 6020000
    Email
    per.cajander@regionorebrolan.se

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Incidence of Dysphagia in Intensive Care Patients With Tracheostomy

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