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

NCT05501015 | Unknown

• 1 other identifier: 1795792-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Extubation Dysphagia

Outcome Measures

Primary Outcomes (1)

• Rehabilitating dysphagia

  Return of swallowing function, assessed by FEES or barium swallow study supervised by a speech language pathologist.

  5-10 days

Study Arms (2)

Group A - Standard Dysphagia Treatment

NO 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.

Group B - Ice Chip Treatment

EXPERIMENTAL

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.

Other: Ice chips

Interventions

Ice chips OTHER

Consuming small amounts of ice chips with supervision

Group B - Ice Chip Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A participant will be included if he/she:
• Has been intubated for greater than 48 hours (about 2 days)
• Can follow simple commands
• Has been extubated
• Can elicit a cough response
• Is on room air, nasal cannula, or high flow oxygen
• Does not currently have pneumonia/aspiration pneumonia
• Can manage secretions

You may not qualify if:

• Has been Intubated for less than 48 hours (about 2 days)
• Is aphonic
• Is unable to manage secretions
• Has prior history of dysphagia
• Is unable to follow directions
• Is on ventilator
• Has oral thrush
• Is unable to elicit a cough

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Related Publications (1)

• Perren A, Zurcher P, Schefold JC. Clinical Approaches to Assess Post-extubation Dysphagia (PED) in the Critically Ill. Dysphagia. 2019 Aug;34(4):475-486. doi: 10.1007/s00455-019-09977-w. Epub 2019 Jan 25.

  PMID: 30684017 BACKGROUND

Central Study Contacts

Zoltan Nemeth, PhD

CONTACT

9739718934; zoltan.nemeth@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: August 15, 2022
• Study Start: May 2, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)