Aspiration in Acute Respiratory Failure Survivors 2

Not Applicable

Recruiting

• Conditions: Aspiration; Dysphagia
• Interventions: Diagnostic Test: 3-Screenings Protocol; Diagnostic Test: FEES; Diagnostic Test: Tracheal Ultrasound

• Registration Number: NCT05108896
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-05
• Study Start: 2021-12-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 855

Inclusion Criteria

1. Admission to an ICU.
2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.

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Exclusion Criteria

1. Likely persistent contraindications to enteral/oral 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 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
8. Extubated for greater than 96 hours.
9. Inability to obtain informed consent from patient or an appropriate surrogate.
10. Age < 18 years.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspiration in Acute Respiratory Failure Survivors	3-Screenings Protocol	All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.
Aspiration in Acute Respiratory Failure Survivors	FEES	All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.
Aspiration in Acute Respiratory Failure Survivors	Tracheal Ultrasound	All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.

Primary Outcome Measures

Name	Time	Method
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies	from extubation day 1 through hospital discharge, expected to be within 28 days	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants experiencing non-silent aspiration	from extubation day 1 through hospital discharge, expected to be within 28 days	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.
Duration required for liberation from mechanical ventilation	from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average	We will also collect the overall length of the liberation process from mechanical ventilation in days
Percentage of participants experiencing silent aspiration	from extubation day 1 through hospital discharge, expected to be within 28 days	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.
Percentage of participants experiencing post-extubation clinical laryngeal edema	Within 24 hours after extubation	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
Duration of mechanical ventilation	from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average	We will also collect the overall length of mechanical ventilation in days

Trial Locations

Locations (5)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Stanford Univerity; 🇺🇸 Stanford, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States