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

Primary Purpose

Post Extubation Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ice chips
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Extubation Dysphagia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Morristown Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group A - Standard Dysphagia Treatment

Group B - Ice Chip Treatment

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
August 12, 2022
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05501015
Brief Title
Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study
Official Title
Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Dysphagia is a swallowing disorder that results in difficulty or inability to transport food or liquid effectively and safely from the mouth to the stomach. If dysphagia is not detected and treated early, it may lead to aspiration and aspiration pneumonia. Aspiration occurs when food, liquid, secretions or stomach contents are inhaled into the lungs. Silent aspiration occurs when food, liquid, secretions or stomach contents are inhaled into the lungs and the patient does not feel it so there is no cough response elicited. Swallowing disorders are often associated with prolonged intubation (>48 hours (about 2 days). The reported incidence of post-extubation dysphagia (PED) varies significantly. One study found that PED was present in 84% of patients, and this was even after the exclusion of patients with stroke or neuromuscular disease. Clinical signs and symptoms of aspiration may be observed by a patient who coughs on their own secretions or coughs when food or liquid is introduced. Silent aspiration is a covert form of aspiration that occurs without any outward signs or symptoms. Silent aspiration is usually a result of desensitization of the pharynx and upper airways and can be diagnosed through an instrumental swallow assessment. A meta -analysis and systematic review systematic including 38 studies, 5798 patients and 1957 dysphagia events noted a high incidence of post-extubation silent aspiration. The authors calculated the combined weighted incidence of post-extubation dysphagia to be 41% (95% confidence interval, 0.33-0.50), with 36% of the patients with PED having silent aspiration (95% confidence interval, 0.22-0.50). Without instrumental swallow evaluations, silent aspiration may go undetected and lead to pulmonary complications. Post-extubation dysphagia has been associated with poor outcomes including increased risk of reintubation, development of pneumonia, prolonged hospital stays, need for feeding tubes, increased hospital costs, malnutrition, dehydration, increased risk of death, discharge to a nursing home and poor quality of life. Additional sequala following post extubation dysphagia may include laryngeal trauma, neuromuscular weakness, reduced ability to coordinate breathing and swallowing, impaired cough response and generalized disuse atrophy. In the critically ill population, there have been only a few studies that analyzed the impact of post-extubation dysphagia on patient centered outcomes. ICU (Intensive Care Unit) acquired weakness (ICUAW) including general muscular weakness and muscular atrophy has not been reported in the literature. ICUAW weakness may be a consequence of disuse in patient's receiving long term intubation, long term sedation and or neuromuscular blocking agents. The "use it or lose it" principle suggest that early intervention can improve diet tolerance, airway protection and overall nutrition. Currently, in our ICU at MMC, when a patient is extubated, they receive a nursing swallowing screen with 3 ounces of water. If the patient fails the nursing swallow screening, they remain NPO (nothing by mouth) and are then seen by a Speech-Language Pathologist (SLP) for a formal Dysphagia Evaluation. The SLP assessment includes a cranial nerve exam, integrity of cough strength, vocal quality, dental status, oral hygiene, and mentation. If the SLP deems the patient safe for oral trials, various textures of food and liquid are introduced. If the patient exhibits overt signs and symptoms of aspiration (coughs when eating or drinking) they are often kept NPO (nil by mouth) and re-assessed in a few days. The ability to detect silent aspiration during a clinical bedside dysphagia evaluation is limited. An instrumental assessment is often recommended as the patient improves which is completed by the SLP. Following these assessments, recommendations are then made to either begin oral intake if patient is safe to eat or remain NPO. Swallow therapy is often not initiated until after the patient is out of ICU. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Extubation Dysphagia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - Standard Dysphagia Treatment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group B - Ice Chip Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ice chips
Intervention Description
Consuming small amounts of ice chips with supervision
Primary Outcome Measure Information:
Title
Rehabilitating dysphagia
Description
Return of swallowing function, assessed by FEES or barium swallow study supervised by a speech language pathologist.
Time Frame
5-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoltan Nemeth, PhD
Phone
9739718934
Email
zoltan.nemeth@atlantichealth.org
Facility Information:
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoltan Nemeth, PhD
Phone
973-971-8934
Email
zoltan.nemeth@atlantichealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30684017
Citation
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.
Results Reference
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Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study

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