Effect of Carbonated Water on Swallowing

NCT06563960 | Enrolling By Invitation DMC

• 1 other identifier: carbonated water
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

intervention

OTHER

patients who drank carbonated water.

Other: carbonated water

Interventions

carbonated water OTHER

Participants will drink carbonated water during videofluoroscopy.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years old;
• Individuals who present penetration and/or laryngotracheal aspiration for liquids during the video swallow examination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (2)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Fabricio Edler Macagnan

Porto Alegre, Rio Grande do Sul, 90035-070, Brazil

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Carbonated Water

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Mineral Waters; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Carbonated Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Drinking Water; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: August 21, 2024
• Study Start: January 2, 2024
• Primary Completion: April 20, 2024
• Study Completion: December 30, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)