Oropharyngeal DysphagiaNCT03284892
Screening and Intervention of Postextubation Dysphagia
A study testing SOC program in people with Oropharyngeal Dysphagia and Swallowing Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia, Swallowing Disorder, Randomized Controlled Trial
- What is being tested?
- SOC program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2017to 8 Aug 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is over 20 years old.
- Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.
Who cannot join
- Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities.
- Patient who has preexisting difficulty swallowing.
- Patient who has received a tracheostomy.
- Patient who were unable to follow verbal instructions.
- Patient who were on contact and droplet precautions (e.g., open tuberculosis)
- Patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an SOC intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia
This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.
Read the detailed description
Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.
- Conditions
- Oropharyngeal Dysphagia, Swallowing Disorder, Randomized Controlled Trial, Endotracheal Intubation
- Being tested
- SOC program
- Keywords
- postextubation dysphagia, endotracheal intubation, randomized controlled trial, dysphagia intervention, dysphagia screening
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC programBehavioural
A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.
| Study group | Role | What they receive |
|---|---|---|
| SOC group | Experimental | Received SOC program addition to usual care Receives: Behavioral: SOC program |
| Control group | No intervention | Received usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resumption of oral feeding
Measured by Functional Oral Intake Scale
Measured: Postextubation 7 days
Incidence of penetration and aspiration
Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure.
Measured: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation
Incidence of pneumonia
Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.
Measured: Postextubation 30 days
Secondary outcomes (4)
Incidence of feeding tube dependency
Abstracted from electronic medical records
Measured: Postextubation 30 days
Unstimulated salivary flow rate (centimeter/5 minutes)
Measured by the whatman 41 test strip
Measured: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Oral health status score
Measured by the oral Assessment Guide
Measured: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Lip closure and lingual diadochokinetic status
Measured by the Frenchay Dysarthria Assessment
Measured: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start19 Sep 2017
- Primary completion8 Aug 2020
- Study completion8 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Cheryl Chia-Hui Chen, Prof., Principal investigator, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284892
- Sponsor's protocol ID
- 201705051RIND
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2017
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siao SF, Ku SC, Tseng WH, Wei YC, Chang YC, Hsiao TY, Wang TG, Chen CC. Effects of a swallowing and oral-care program on resuming oral feeding and reducing pneumonia in patients following endotracheal extubation: a randomized, open-label, controlled trial. Crit Care. 2023 Jul 12;27(1):283. doi: 10.1186/s13054-023-04568-6.
PubMed 37438759Siao SF, Tseng WH, Wang TG, Wei YC, Hsiao TY, Ku SC, Chen CC. Predicting feeding-tube dependence in patients following endotracheal extubation: a two-item swallowing screen. BMC Pulm Med. 2021 Dec 6;21(1):403. doi: 10.1186/s12890-021-01771-5.
PubMed 34872549
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia
- ClinicalTrials.gov ID
- NCT03284892
- Acronym / sponsor ID
- 201705051RIND
- Conditions
- Oropharyngeal Dysphagia, Swallowing Disorder, Randomized Controlled Trial, Endotracheal Intubation
- Keywords
- postextubation dysphagia, endotracheal intubation, randomized controlled trial, dysphagia intervention, dysphagia screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 15 Sep 2017 (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.
This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.
Detailed description
Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.
| Arm | Type | Receives |
|---|---|---|
| SOC group | Experimental | Behavioral: SOC programReceived SOC program addition to usual care |
| Control group | No intervention | –Received usual care only |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who is over 20 years old.
- Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.
Key exclusion criteria (6 listed)
- Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities.
- Patient who has preexisting difficulty swallowing.
- Patient who has received a tracheostomy.
- Patient who were unable to follow verbal instructions.
- Patient who were on contact and droplet precautions (e.g., open tuberculosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOC programA once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education. | Behavioural | SOC group |
Primary outcome
Resumption of oral feeding
Time frame: Postextubation 7 days
Measured by Functional Oral Intake Scale
Incidence of penetration and aspiration
Time frame: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation
Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure.
Incidence of pneumonia
Time frame: Postextubation 30 days
Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.
4 secondary outcomes
Incidence of feeding tube dependency
Time frame: Postextubation 30 days
Unstimulated salivary flow rate (centimeter/5 minutes)
Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Oral health status score
Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Lip closure and lingual diadochokinetic status
Time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 37438759Siao SF, Ku SC, Tseng WH, Wei YC, Chang YC, Hsiao TY, Wang TG, Chen CC. Effects of a swallowing and oral-care program on resuming oral feeding and reducing pneumonia in patients following endotracheal extubation: a randomized, open-label, controlled trial. Crit Care. 2023 Jul 12;27(1):283. doi: 10.1186/s13054-023-04568-6.
- Derived from this study: PubMed 34872549Siao SF, Tseng WH, Wang TG, Wei YC, Hsiao TY, Ku SC, Chen CC. Predicting feeding-tube dependence in patients following endotracheal extubation: a two-item swallowing screen. BMC Pulm Med. 2021 Dec 6;21(1):403. doi: 10.1186/s12890-021-01771-5.
- Individual participant dataSharing planned: Undecided
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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.
Cheryl Chia-Hui Chen, Prof. principal investigator
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC program in people with Oropharyngeal Dysphagia and Swallowing Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 20 Jul 2023. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resumption of oral feeding (time frame: Postextubation 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284892, which also lists 2 linked publications.
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 20 Jul 2023.