Post-extubation DysphagiaNCT03761823
Post-extubation Dysphagia
An observational study of Post-extubation Dysphagia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-extubation Dysphagia
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2019to 28 Feb 2019
- Phase
- Observational
- 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
Study population: Healthy subjects will be recruited using posters at the local university and the internet. Intensive care patients that will be extubated shortly.
Who may be able to join
- age > 18 years
- informed consent
- extubated after endotracheal intubation for more than 5 days
- Richmond Agitation-Sedation Scale (RASS) between -2 and 2
- able to sit right up
- no respiratory insufficiency/failure (for this study defined as oxygen saturation (SpO2) < 92% with a minimum of 3 L nasal oxygen)
- age > 18 years
- informed consent
Who cannot join
- pre-existing dysphagia (according to medical record and screening)
- tracheostomy or previous tracheostomy
- history of prior intubation < 3 months ago
- head/neck surgery, head/neck radiation or head/neck disease
- pre-existent esophageal disorder
- coagulopathy (thrombocytes < 50*10^9 /l, or prothrombin time (PT)/activated partial thromboplastin time (APTT) > 1.5 times the reference value, or fibrinogen < 1000 mg/l, or use of therapeutic anticoagulant drugs)
Show all 9Show fewer
- allergy for xylometazoline (only in case its use is indicated)
- known pregnancy
- known G6PD deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pathophysiology of Post-extubation Dysphagia in ICU Patients
Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED) is unknown. This exploratory pilot study is the first step that aims to fill this knowledge gap to ultimately improve current treatment and prevention of post-extubation dysphagia.
Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients within 24 hours after extubation will be studied.
Read the detailed description
Observational study model:
The group of healthy subjects will be recruited using posters at the local university and the internet. The healthy subjects will be studied before the group of patients to assess the feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then, the group of patients will be studied. They will be recruited from the Intensive Care Unit. See In- and Exclusion criteria for details.
- Conditions
- Post-extubation Dysphagia
- Keywords
- Flexible endoscopic evaluation of swallowing, High resolution impedance manometry, Electromyography, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects | |
| Patients | Patients extubated after > 5 days of mechanical ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with aspiration during FEES will be assessed.
Measured: At time of measurement (within 24 hours post-extubation)
Secondary outcomes (4)
Pathophysiology of PED
The pathophysiology of PED will be determined after simultaneous measurement of FEES, HRIM and EMG. The pathophysiology will be classified into several categories: reduced pharyngeal contractility / muscular weakness, reduced upper esophageal sphincter (UES) opening/relaxation, direct oropharyngeal or laryngeal trauma of the tube, reduced laryngeal sensibility, among other categories. To enable classification, parameters obtained from FEES, HRIM and EMG will be used. FEES: presence of penetration and aspiration, residue, reduced sensibility (among others); HRIM: pharyngeal peak pressure, UES maximum admittance, intrabolus pressure (among others); EMG: duration of muscle activity (among others).
Measured: At time of measurement (within 24 hours post-extubation)
The number of adverse events will be assessed.
Measured: Participants will be followed until hospital discharge, an expected average of 28 days
Interaction of FEES on HRIM recording
HRIM outcomes during the simultaneous recording will be compared with outcomes of recording with only HRIM in situ.
Measured: At time of measurement (within 24 hours post-extubation)
Correlation of FEES with HRIM
The correlation of FEES outcomes, e.g. PAS and residue, with HRIM outcomes, e.g. swallow risk index and post-swallow impedance ratio.
Measured: At time of measurement (within 24 hours post-extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start22 Jan 2019
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Why it stopped: Organizational issues and slow inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-extubation DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes G. van der Hoeven, prof. dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761823
- Sponsor's protocol ID
- DYSPHAGIA ICU HH17
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathophysiology of Post-extubation Dysphagia in ICU Patients
- ClinicalTrials.gov ID
- NCT03761823
- Acronym / sponsor ID
- DYSPHAGIA ICU HH17
- Conditions
- Post-extubation Dysphagia
- Keywords
- Flexible endoscopic evaluation of swallowing, High resolution impedance manometry, Electromyography, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Organizational issues and slow inclusion rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED) is unknown. This exploratory pilot study is the first step that aims to fill this knowledge gap to ultimately improve current treatment and prevention of post-extubation dysphagia.
Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients within 24 hours after extubation will be studied.
Detailed description
Observational study model:
The group of healthy subjects will be recruited using posters at the local university and the internet. The healthy subjects will be studied before the group of patients to assess the feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then, the group of patients will be studied. They will be recruited from the Intensive Care Unit. See In- and Exclusion criteria for details.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –Healthy subjects |
| Patients | – | –Patients extubated after > 5 days of mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects will be recruited using posters at the local university and the internet. Intensive care patients that will be extubated shortly.
Key inclusion criteria (8 listed)
- age > 18 years
- informed consent
- extubated after endotracheal intubation for more than 5 days
- Richmond Agitation-Sedation Scale (RASS) between -2 and 2
- able to sit right up
Key exclusion criteria (9 listed)
- pre-existing dysphagia (according to medical record and screening)
- tracheostomy or previous tracheostomy
- history of prior intubation < 3 months ago
- head/neck surgery, head/neck radiation or head/neck disease
- pre-existent esophageal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients with aspiration during FEES will be assessed.
Time frame: At time of measurement (within 24 hours post-extubation)
4 secondary outcomes
Pathophysiology of PED
Time frame: At time of measurement (within 24 hours post-extubation)
The number of adverse events will be assessed.
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
Interaction of FEES on HRIM recording
Time frame: At time of measurement (within 24 hours post-extubation)
Correlation of FEES with HRIM
Time frame: At time of measurement (within 24 hours post-extubation)
Results and safety
The study was stopped early (reason given: Organizational issues and slow inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Related trials for Post-extubation Dysphagia
RecruitingObservational study
Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients
Dysphagia, Sarcopenia
Recruiting
Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU
Swallowing Disorders, Aspiration
Not yet recruitingObservational study
Silent Aspiration Following Extubation in the ICU
Silent Aspiration, Post-Extubation Dysphagia
RecruitingPhase 2
Corticosteroids for Post-Extubation Dysphagia
Dysphagia, Laryngeal Edema
Active, not recruiting
High-frequency Repetitive Transcranial Magnetic Stimulation for Patients With Dysphagia After Extubation
Post-extubation Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes G. van der Hoeven, prof. dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-extubation Dysphagia, run by Radboud University Medical Center at 1 site in Netherlands.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Organizational issues and slow inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with aspiration during FEES will be assessed. (time frame: At time of measurement (within 24 hours post-extubation)). 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 11 Apr 2024.