Recruiting

Functional Rehabilitation

Sponsor:

Atlantic Health System

Code:

NCT05501015

Conditions

Post Extubation Dysphagia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ice chips

Study Details

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

Study ID

NCT05501015

Start date

May 2, 2022

Status verified date

Aug, 2022

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Group A - Standard Dysphagia Treatment

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.

experimental: Group B - Ice Chip Treatment

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.

Interventions

Ice chips

Consuming small amounts of ice chips with supervision

Primary outcome measure

  • Rehabilitating dysphagia [ Time Frame: 5-10 days ]

Central Contacts and Locations

Central contacts

Locations

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

More Information

Sponsor

Atlantic Health System

Last update posted

Aug 15, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2022-08-15.