DysphagiaNCT06563960
Effect of Carbonated Water on Swallowing
A study testing carbonated water in people with Dysphagia, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial summary
Swallowing has an important function in the lives of individuals, it is related to moments of socialization, pleasure, nutrition and also helps protect against the entry of food, saliva or other material towards the lungs (penetration and/or laryngotracheal aspiration). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- carbonated water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Jan 2024to 30 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old;
- Individuals who present penetration and/or laryngotracheal aspiration for liquids during the video swallow examination.
Who cannot join
- Patients with contraindication to liquid testing (those with evidence of massive aspiration of moderately thickened food where it is necessary to interrupt examination per safety protocol, who have previously had a tracheoesophageal fistula diagnosed or who do not present any swallowing response);
- Individuals who present clinical instability and sensory oscillation that make it impossible to carrying out the exam;
- Individuals who present postural changes that limit positioning for carrying out the exam;
- Patients who are allergic to barium contrast.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Fabricio Edler Macagnan
Porto Alegre, Rio Grande do Sul, 90035-070
About this study
Official title: Effect of Carbonated Water on Swallowing in Patients With Liquid Dysphagia
Swallowing has an important function in the lives of individuals, it is related to moments of socialization, pleasure, nutrition and also helps protect against the entry of food, saliva or other material towards the lungs (penetration and/or laryngotracheal aspiration). A Difficulty in swallowing is called dysphagia and therapeutic strategies are necessary to help the affected individuals. The use of carbonated water as a therapeutic strategy has been used, however, there are still few studies on the topic. In the search for therapeutic strategies viable and easy to insert into the clinical routine and daily lives of patients, this study aims to verify the effect of carbonated water on swallowing liquids for patients with dysphagia diagnosed by videodeglutogram examination, through comparison with non-water carbonated. The present study aims to generate scientific evidence about the effect of water carbonated drink as a strategy in patients with liquid dysphagia, with the aim of helping professional speech therapist and other professionals involved in the therapeutic process, in order to improve the health and quality of life of dysphagic patients and contribute to the evolution of knowledge in the field of dysphagia. This is a clinical trial, all participants will be included adult patients to carry out the video swallow examination, which present aspiration and/or laryngotracheal penetration of liquids during the performance of the and who agree to participate in the research. The effect of carbonated water on levels of penetration and/or laryngotracheal aspiration in relation to the use of non-carbonated water, and analyzed whether the results obtained with the use of carbonated water have behavior similar between the different patient profiles studied.
Read the detailed description
This is a clinical trial. The study population comprises all adult dysphagic patients who present laryngotracheal penetration and/or aspiration of liquids during the videodeglutogram exam, performed at the aforementioned Imaging Diagnosis Center, during the period from March to December 2023 and who agree to participate. Therefore, a convenience sample will be used.
The study population will consist of all patients who present laryngotracheal penetration and/or aspiration of liquids during the videodeglutogram exam performed at the institution's Imaging Diagnosis Center and who agree to participate in the study. The anamnesis was constructed by the research team, aiming to collect information about the target population (age, sex, marital status, education, underlying pathology, main complaint and swallowing difficulties). In addition, for those who have a history in the electronic medical record, the same will be consulted to verify information regarding the history of previous illnesses, medications in use and general health conditions. The examination will be performed by the technically responsible speech therapist, with experience in the area. It consists of offering food to the patient (thin liquid - water, moderately thickened - yogurt, soft solid - bread and hard - crackers), impregnated with a barium contrast; during swallowing, dynamic, real-time images are captured by an x-ray equipment, making it possible to evaluate all phases of swallowing, following the path of the food from the mouth to the stomach. The following aspects will be checked: oral preparation of the food, ejection of the bolus, the existence of early food escape and identification of the location of the beginning of the pharyngeal phase of swallowing, the presence of stasis in valleculae and pyriform sinuses, episodes of laryngotracheal penetration and/or aspiration, and changes in esophageal motility. Some compensatory strategies, such as head positioning and airway protection maneuvers, may be tested during the examination. Patients who present laryngotracheal penetration and/or aspiration with thin liquid will be subjected to the ingestion of carbonated water in order to verify whether there will be a change in the pattern of laryngotracheal penetration and/or aspiration. The carbonated water chosen for the study was the brand; for every 60ml of water, 1.8ml of barium (3% concentration) will be mixed, the contrast required for the images to be captured in the videofluoroscopy examination. To classify the functional severity of dysphagia and describe laryngotracheal penetration and/or aspiration, the following scales will be considered: Dysphagia Outcome and Severity Scale (DOSS) and Rosenbek Scale. The classification for evaluating the biomechanics of swallowing will be made based on the results of the videofluoroscopy exam, which will be performed.
- Conditions
- Dysphagia
- Being tested
- carbonated water
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbonated waterOther
Participants will drink carbonated water during videofluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Other | patients who drank carbonated water. Receives: Other: carbonated water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who reduce or eliminate penetration and/or aspiration with carbonated water.
Check for how many participants this strategy is effective in reducing penetration and/or aspiration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start2 Jan 2024
- Primary completion20 Apr 2024
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563960
- Sponsor's protocol ID
- carbonated water
- Status last verified
- Aug 2024
- First submitted
- 1 Jun 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carbonated Water on Swallowing in Patients With Liquid Dysphagia
- ClinicalTrials.gov ID
- NCT06563960
- Acronym / sponsor ID
- carbonated water
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
Swallowing has an important function in the lives of individuals, it is related to moments of socialization, pleasure, nutrition and also helps protect against the entry of food, saliva or other material towards the lungs (penetration and/or laryngotracheal aspiration). A Difficulty in swallowing is called dysphagia and therapeutic strategies are necessary to help the affected individuals. The use of carbonated water as a therapeutic strategy has been used, however, there are still few studies on the topic. In the search for therapeutic strategies viable and easy to insert into the clinical routine and daily lives of patients, this study aims to verify the effect of carbonated water on swallowing liquids for patients with dysphagia diagnosed by videodeglutogram examination, through comparison with non-water carbonated. The present study aims to generate scientific evidence about the effect of water carbonated drink as a strategy in patients with liquid dysphagia, with the aim of helping professional speech therapist and other professionals involved in the therapeutic process, in order to improve the health and quality of life of dysphagic patients and contribute to the evolution of knowledge in the field of dysphagia. This is a clinical trial, all participants will be included adult patients to carry out the video swallow examination, which present aspiration and/or laryngotracheal penetration of liquids during the performance of the and who agree to participate in the research. The effect of carbonated water on levels of penetration and/or laryngotracheal aspiration in relation to the use of non-carbonated water, and analyzed whether the results obtained with the use of carbonated water have behavior similar between the different patient profiles studied.
Detailed description
This is a clinical trial. The study population comprises all adult dysphagic patients who present laryngotracheal penetration and/or aspiration of liquids during the videodeglutogram exam, performed at the aforementioned Imaging Diagnosis Center, during the period from March to December 2023 and who agree to participate. Therefore, a convenience sample will be used.
The study population will consist of all patients who present laryngotracheal penetration and/or aspiration of liquids during the videodeglutogram exam performed at the institution's Imaging Diagnosis Center and who agree to participate in the study. The anamnesis was constructed by the research team, aiming to collect information about the target population (age, sex, marital status, education, underlying pathology, main complaint and swallowing difficulties). In addition, for those who have a history in the electronic medical record, the same will be consulted to verify information regarding the history of previous illnesses, medications in use and general health conditions. The examination will be performed by the technically responsible speech therapist, with experience in the area. It consists of offering food to the patient (thin liquid - water, moderately thickened - yogurt, soft solid - bread and hard - crackers), impregnated with a barium contrast; during swallowing, dynamic, real-time images are captured by an x-ray equipment, making it possible to evaluate all phases of swallowing, following the path of the food from the mouth to the stomach. The following aspects will be checked: oral preparation of the food, ejection of the bolus, the existence of early food escape and identification of the location of the beginning of the pharyngeal phase of swallowing, the presence of stasis in valleculae and pyriform sinuses, episodes of laryngotracheal penetration and/or aspiration, and changes in esophageal motility. Some compensatory strategies, such as head positioning and airway protection maneuvers, may be tested during the examination. Patients who present laryngotracheal penetration and/or aspiration with thin liquid will be subjected to the ingestion of carbonated water in order to verify whether there will be a change in the pattern of laryngotracheal penetration and/or aspiration. The carbonated water chosen for the study was the brand; for every 60ml of water, 1.8ml of barium (3% concentration) will be mixed, the contrast required for the images to be captured in the videofluoroscopy examination. To classify the functional severity of dysphagia and describe laryngotracheal penetration and/or aspiration, the following scales will be considered: Dysphagia Outcome and Severity Scale (DOSS) and Rosenbek Scale. The classification for evaluating the biomechanics of swallowing will be made based on the results of the videofluoroscopy exam, which will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Other: carbonated waterpatients who drank carbonated water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over 18 years old;
- Individuals who present penetration and/or laryngotracheal aspiration for liquids during the video swallow examination.
Key exclusion criteria (4 listed)
- Patients with contraindication to liquid testing (those with evidence of massive aspiration of moderately thickened food where it is necessary to interrupt examination per safety protocol, who have previously had a tracheoesophageal fistula diagnosed or who do not present any swallowing response);
- Individuals who present clinical instability and sensory oscillation that make it impossible to carrying out the exam;
- Individuals who present postural changes that limit positioning for carrying out the exam;
- Patients who are allergic to barium contrast.
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 |
|---|---|---|
| carbonated waterParticipants will drink carbonated water during videofluoroscopy. | Other | intervention |
Primary outcome
Number of participants who reduce or eliminate penetration and/or aspiration with carbonated water.
Time frame: 12 months
Check for how many participants this strategy is effective in reducing penetration and/or aspiration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbonated water in people with Dysphagia, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
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?
Number of participants who reduce or eliminate penetration and/or aspiration with carbonated water. (time frame: 12 months). 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 21 Aug 2024.