Ice Chips for Swallowing Difficulty

Overseen By Zoltan Nemeth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Aphonic, Prior dysphagia, Oral thrush, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 5-10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines ways to assist individuals who struggle with swallowing after removal from a breathing tube in the ICU. The researchers aim to determine if early initiation of swallowing exercises can facilitate resumption of eating and drinking, shorten ICU stays, and reduce reliance on feeding tubes. Participants will join one of two groups: one will perform traditional swallowing exercises (Functional Oral-Pharyngeal Rehabilitation), while the other will consume ice chips under supervision. Suitable candidates have been on a breathing tube for more than two days, can follow simple commands, and can cough. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery for future ICU patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this swallowing intervention is safe for post extubated ICU patients?

Research shows that using ice chips in swallowing therapy is generally safe. Past studies have found ice chips harmless even if they accidentally enter the lungs, which is crucial for individuals with swallowing issues, such as those in the ICU. Ice chips are safe because they consist of water that melts quickly and doesn't cause harm if swallowed incorrectly.

Many studies have reported positive results from using ice chips without major problems. For instance, one study reviewing nine cases found that most patients benefited from using ice chips, with 77.8% of the cases showing improvements without any negative effects.

Overall, the ice chip method is well-tolerated and considered a safe way to assist people with swallowing difficulties. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ice chip technique for treating dysphagia because it offers a fresh approach compared to traditional exercises like the effortful swallow or the Masako Maneuver. Unlike standard methods, the ice chip protocol involves consuming small, supervised amounts of ice chips, which are easy for patients with severe swallowing difficulties to manage. The ice chips act as a cohesive bolus, making swallowing safer and more controlled. Plus, this method is based on the Frazier Free Water Protocol, suggesting that small amounts of ice are safe even if aspirated, making it a potentially more comfortable and less risky option for patients.

What evidence suggests that this trial's treatments could be effective for minimizing aspiration risk in post extubated ICU patients?

Research has shown that ice chips can aid people with dysphagia, a condition that makes swallowing difficult. In this trial, participants in Group B will receive ice chip treatment. Previous studies found that 77.8% of people using ice chips experienced positive results, such as reduced saliva. Patients can easily manage ice chips in their mouths, making them safer to swallow, even if some are accidentally inhaled. Small amounts of ice or water are generally not harmful if they enter the lungs. This approach might help patients begin eating by mouth sooner. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Has been extubated

Is on room air, nasal cannula, or high flow oxygen

You have been on a breathing machine for more than 48 hours (about 2 days).

Exclusion Criteria

You have difficulty managing your own body fluids.

You are unable to speak.

You have a history of difficulty swallowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants receive a Clinical Dysphagia Evaluation and a Fiberoptic Endoscopic Evaluation of Swallowing (FEES) by a Speech-Language Pathologist

1 day

1 visit (in-person)

Treatment

Participants are randomly assigned to Group A or B. Group A receives traditional dysphagia exercises, while Group B consumes ice chips with supervision, both three times a day.

5-10 days

Daily in-person sessions

Follow-up

Participants are monitored for the return of swallowing function, assessed by FEES or barium swallow study

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Oral-Pharyngeal Rehabilitation
• Ice chips

How Is the Trial Designed?

Group I: Group B - Ice Chip Treatment Experimental Treatment 1 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 Treatment Active Control 1 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.

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Published Research Related to This Trial

The modified jaw opening exercise (MJOE) was found to be safe and feasible for post-stroke patients with dysphagia, with no reported pain during the exercise regimen.

After six weeks of MJOE, participants showed significant improvements in hyoid displacement during swallowing, indicating its effectiveness in enhancing swallowing function compared to a control exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. Koyama, Y., Sugimoto, A., Hamano, T., et al.[2017]

Citations

1. pubs.asha.org pubs.asha.org/doi/abs/10.1044/persp3.SIG13.28

The Ice Chip Protocol: A Description of the ... We demonstrate that the Ice Chip Protocol led to positive outcomes in the majority of the case reports. In 77.8% of the cases (7/9), secretion amount and ...

2. researchgate.net researchgate.net/publication/323788713_The_Ice_Chip_Protocol_A_Description_of_the_Protocol_and_Case_Reports

(PDF) The Ice Chip Protocol: A Description of ... Result We demonstrate that the Ice Chip Protocol led to positive outcomes in the majority of the case reports. In 77.8% of the cases (7/9), ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9950376/

Implementation of a free water protocol at a long term acute ... This feasibility study aimed to trial a Free Water Protocol (FWP) for patients with thin liquid dysphagia in the Long-Term Acute Care Hospital (LTACH) setting.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05501015

Functional Oral-Pharyngeal Rehabilitation of Patients With ... Ice chips provide additional advantages in rehabilitating dysphagia as they are a cohesive bolus that are easier for patients with severe ...

5. link.springer.com link.springer.com/article/10.1007/s00455-025-10805-7

A Mixed Methods Systematic Review | Dysphagia Free water protocols (FWP) give patients at risk of aspiration the option to drink water between meals. Evidence is lacking about their use ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10781836/

Dysphagia Prevalence and Outcomes Associated with the ... Prevalence of dysphagia was 94% with the majority (45%) exhibiting profound dysphagia (Functional Oral Intake Scale = 1) at initial assessment.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05501015/functional-oral-pharyngeal-rehabilitation-of-patients-with-dysphagia-using-ice-chips-a-prospective-randomized-study

Functional Oral-Pharyngeal Rehabilitation of Patients With ... The objective of this study is to evaluate the effectiveness of early swallowing intervention in post extubated patients in the ICU.