- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874352
Incidence of Dysphagia in Intensive Care Patients With Tracheostomy
Incidence of Dysphagia in Intensive Care Patients With Tracheostomy Using High Resolution Pharyngoesophageal Manometry and Impedance
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johanna Savilampi
- Phone Number: +46 019 6020266
- Email: johanna.savilampi@regionorebrolan.se
Study Contact Backup
- Name: Per Cajander
- Phone Number: +46 019 6020000
- Email: per.cajander@regionorebrolan.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: intensive care patients
intensive care patients with tracheostomy/ high resolution impedance manometry with Automated Impedance Manometry analysis
|
|
Other: healthy volunteers
control group with healthy volunteers/ high resolution impedance manometry with Automated Impedance Manometry analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Flow Measurements
Time Frame: 1 hour
|
Pressure Flow measurements generated by HRIM registrations and analysed by AIM analysis
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sydney Swallow Questionaire (SSQ)
Time Frame: 1 hour
|
Clinical swallow assessment
|
1 hour
|
Functional Oral Intake Scale (FOIS)
Time Frame: 1 hour
|
Clinical swallow assessment
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysphagia
-
Morinaga Milk Industry Co., LTDHospital de MataróRecruitingDysphagia | Swallowing Disorder | Dysphagia, Oral Phase | Dysphagia, Esophageal | Dysphagia, OropharyngealSpain
-
All India Institute of Medical Sciences, New DelhiRecruitingOropharyngeal Dysphagia | Dysphagia, Late Effect of Stroke | Transfer Dysphagia | Cricopharyngeus Muscle DysfunctionIndia
-
National Taiwan University HospitalRecruitingDysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationTaiwan
-
University of Southern CaliforniaRecruitingDysphagia | Pharyngeal Dysphagia | Oral Pharyngeal DysphagiaUnited States
-
Peter Belafsky, MDTerminatedDysphagia | Oropharyngeal Dysphagia (OPD)United States
-
Atlantic Health SystemRecruitingPost Extubation DysphagiaUnited States
-
University of California, DavisCalifornia Institute for Regenerative Medicine (CIRM); Cook MyoSiteRecruitingOropharyngeal DysphagiaUnited States
-
University of British ColumbiaB.C. Rehabilitation FoundationCompletedThin Liquid DysphagiaCanada
-
Umm Al-Qura UniversityCompleted
-
NestléCompleted
Clinical Trials on high resolution impedance manometry with Automated Impedance Manometry analysis
-
Great Ormond Street Hospital for Children NHS Foundation...National Institute for Health Research, United KingdomRecruitingEsophageal Atresia With Tracheoesophageal FistulaUnited Kingdom
-
Evangelic Hospital Kalk CologneCompletedAnxiety Disorders | GERD - Gastro-Esophageal Reflux DiseaseGermany
-
National Taiwan University HospitalNot yet recruitingthe Correlation Between the Barium Examination and High Resolution Impedance Manometry
-
The Catholic University of KoreaCompletedIschemic StrokeKorea, Republic of
-
University of LouisvilleWithdrawnChest Pain | Dysphagia | GERD | Achalasia | Post FundoplicationUnited States
-
Hospices Civils de LyonCompleted
-
Hospices Civils de LyonRecruiting
-
IRCCS Policlinico S. DonatoUniversity of Pisa; Medical University of Vienna; Washington University School... and other collaboratorsCompleted
-
University Hospital, RouenNot yet recruiting
-
University Hospital, RouenCompleted