Incidence of Dysphagia in Intensive Care Patients With Tracheostomy
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
August 22, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedAugust 23, 2016
August 1, 2016
1.6 years
August 17, 2016
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pressure Flow Measurements
Pressure Flow measurements generated by HRIM registrations and analysed by AIM analysis
1 hour
Secondary Outcomes (2)
Sydney Swallow Questionaire (SSQ)
1 hour
Functional Oral Intake Scale (FOIS)
1 hour
Study Arms (2)
intensive care patients
OTHERintensive care patients with tracheostomy/ high resolution impedance manometry with Automated Impedance Manometry analysis
healthy volunteers
OTHERcontrol group with healthy volunteers/ high resolution impedance manometry with Automated Impedance Manometry analysis
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pre-existing dysphagia
- History of upper gastrointestinal surgery
- Current medication known to affect esophageal motility
- Pregnancy
- Severe coagulopathy
- Allergy to local anaesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
August 22, 2016
Study Start
October 1, 2016
Primary Completion
May 1, 2018
Study Completion
September 1, 2018
Last Updated
August 23, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share