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Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study
N/A
Waitlist Available
Research Sponsored by Atlantic Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-10 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two ways to help ICU patients who have just had a breathing tube removed to start swallowing safely again. One group will do traditional swallowing exercises, and the other group will eat small amounts of ice chips. Both methods aim to strengthen the muscles used for swallowing and help patients start eating and drinking safely sooner.
Eligible Conditions
- Swallowing Difficulty
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-10 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rehabilitating dysphagia
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group B - Ice Chip TreatmentExperimental Treatment1 Intervention
Group B will serve as the experimental group. In place of traditional dysphagia exercises, participants in Group B will receive oral hygiene and will consume small amounts of ice chips with supervision, three times a day. The ice chip protocol is based on the same findings as the Frazier Free Water Protocol, in that small amounts of clean water or ice chips are not harmful to the lungs and relatively benign if aspirated. Ice chips provide additional advantages in rehabilitating dysphagia as they are a cohesive bolus that are easier for patients with severe dysphagia to control in their mouth and swallow.
Group II: Group A - Standard Dysphagia TreatmentActive Control1 Intervention
Group A will serve as the control group. This group will receive oral hygiene followed by traditional dysphagia exercises, including effortful swallow, Masako Maneuver, and Tongue Press.
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Who is running the clinical trial?
Atlantic Health SystemLead Sponsor
55 Previous Clinical Trials
7,477 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulty managing your own body fluids.You are unable to speak.You have been on a breathing machine for more than 48 hours (about 2 days).You have a history of difficulty swallowing.You are currently on a machine to help you breathe.You are able to cough when asked.You can control your body's fluids (like saliva).You cannot cough.
Research Study Groups:
This trial has the following groups:- Group 1: Group A - Standard Dysphagia Treatment
- Group 2: Group B - Ice Chip Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.