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Not listed Not applicable Interventional

Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study

ClinicalTrials.gov ID: NCT05501015

Public ClinicalTrials.gov record NCT05501015. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 12:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study is to evaluate the effectiveness of early swallowing intervention in post extubated patients in the ICU to determine if this minimizes the risk of aspiration, increases initiating of oral intake sooner, reduced length of ICU stay and reduces the need for alternate means of nutrition/hydration. Patients will be randomly assigned to either Group A or B. We will decide grouping, using wheel that will randomly select group A or B after spinning. All participants will receive ongoing therapy while enrolled in the study until they receive an oral diet or are placed on a feeding tube as directed by their physician. Participants will be assigned to be in Group A or B. In Group A, participants will receive traditional swallowing therapy and perform exercises to strengthen swallowing muscles three times a day, while in Group B, participants will consume ice chips with supervision three times a day, which is also to strengthen swallowing muscles. Before starting therapy, all participants will receive a Clinical Dysphagia Evaluation by a Speech-Language Pathologist and an instrumental swallowing assessment by a Speech-Language Pathologist called a Fiberoptic Endoscopic Evaluation of Swallowing -(FEES). The FEES is an objective exam where a small, thin fiberoptic endoscope is placed trans nasally by the SLP. The assessment determines if a patient is aspirating, what texture of food and /or liquid the patient is aspirating, assesses ability to manage secretions, assesses vocal fold movement and determines if patient is safe to begin oral intake. 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. This will occur three times a day. 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.

Study identification

NCT ID
NCT05501015
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Atlantic Health System
Other
Enrollment
100 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 1, 2022
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023
Last update posted
Aug 14, 2022

2022 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Morristown Medical Center Morristown New Jersey 07960 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05501015, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 14, 2022 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05501015 live on ClinicalTrials.gov.

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