Aspiration in Acute Respiratory Failure Survivors 2

Dysphagia Clinical Trial

Official title:

Aspiration in Acute Respiratory Failure Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108896
• Other study ID #: 21-3873
• Secondary ID: R01NR019989
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: December 15, 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Jeff McKeehan, RN,MSN
• Phone: 3037246080
• Email: jeffrey.mckeehan[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.

Description:

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 855
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Admission to an ICU.

2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.

Exclusion Criteria:

1. Contraindication to enteral nutrition administration.

2. Pre-existing history of dysphagia or aspiration.

3. Pre-existing or acute primary central or peripheral neuromuscular disorder.

4. Presence of a chronic tracheostomy (present prior to ICU admission).

5. Pre-existing head and neck cancer or surgery.

6. Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.

7. Delirium for more than 72 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).

8. Extubated for greater than 72 hours.

9. Inability to obtain informed consent from patient or an appropriate surrogate.

10. Age < 18 years.

Related Conditions & MeSH terms

• Aspiration
• Dysphagia
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• 3-Screenings Protocol
The 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST).
• FEES
A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
• Tracheal Ultrasound
Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Boston University	Boston	Massachusetts
United States	Yale University	New Haven	Connecticut
United States	Stanford Univerity	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (112)

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* Note: There are 112 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies	Aspiration (PAS score of =6) on the FEES with any of the feeding consistencies. A PAS score of = 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of =6 on FEES, patients will be stratified by aspiration on any of the five consistencies.	from extubation day 1 through hospital discharge, expected to be within 28 days
Secondary	Percentage of participants experiencing non-silent aspiration	We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of =6) on the FEES with any of the feeding consistencies. A PAS score of = 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of =6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types.	from extubation day 1 through hospital discharge, expected to be within 28 days
Secondary	Percentage of participants experiencing silent aspiration	We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of =6) on the FEES with any of the feeding consistencies. A PAS score of = 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of =6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types.	from extubation day 1 through hospital discharge, expected to be within 28 days
Secondary	Percentage of participants experiencing post-extubation clinical laryngeal edema	We will define laryngeal edema as upper-airway obstruction within 24 hours after extubation. Minor laryngeal edema will be defined as stridor associated with a respiratory distress defined as a prolonged inspiratory phase and the presence of edema on FEES examination. Major laryngeal edema will defined as severe respiratory distress needing tracheal reintubation secondary to upper-airway obstruction that was visualized during the FEES examination	Within 24 hours after extubation
Secondary	Duration of mechanical ventilation	We will also collect the overall length of mechanical ventilation in days	from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Secondary	Duration required for liberation from mechanical ventilation	We will also collect the overall length of the liberation process from mechanical ventilation in days	from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average