Post Extubation DysphagiaNCT05501015
Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study
A study testing Ice chips in people with Post Extubation Dysphagia, run by Atlantic Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post Extubation Dysphagia
- What is being tested?
- Ice chips
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Zoltan Nemeth, PhD, 973-971-8934, zoltan.nemeth@atlantichealth.org
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Post Extubation Dysphagia
- Being tested
- Ice chips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice chipsOther
Consuming small amounts of ice chips with supervision
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ice chips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitating dysphagia
Return of swallowing function, assessed by FEES or barium swallow study supervised by a speech language pathologist.
Measured: 5-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start2 May 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Extubation DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoltan Nemeth, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501015
- Sponsor's protocol ID
- 1795792-2
- Status last verified
- Aug 2022
- First submitted
- 22 Mar 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30684017
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05501015
- Acronym / sponsor ID
- 1795792-2
- Conditions
- Post Extubation Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Ice chipsGroup 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice chipsConsuming small amounts of ice chips with supervision | Other | Group B - Ice Chip Treatment |
Primary outcome
Rehabilitating dysphagia
Time frame: 5-10 days
Return of swallowing function, assessed by FEES or barium swallow study supervised by a speech language pathologist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 30684017Perren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice chips in people with Post Extubation Dysphagia, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoltan Nemeth, PhD (9739718934, zoltan.nemeth@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitating dysphagia (time frame: 5-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.