RecruitingNot ApplicableNCT05108896

Aspiration in Acute Respiratory Failure Survivors 2

Aspiration in Acute Respiratory Failure Survivors

Sponsor

University of Colorado, Denver

Enrollment

855 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Aspiration Dysphagia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria10

Likely persistent contraindications to enteral/oral nutrition administration.
Pre-existing history of dysphagia or aspiration.
Pre-existing or acute primary central or peripheral neuromuscular disorder.
Presence of a chronic tracheostomy (present prior to ICU admission).
Pre-existing head and neck cancer or surgery.
Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
Delirium for more than 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
Extubated for greater than 96 hours.
Inability to obtain informed consent from patient or an appropriate surrogate.
Age \< 18 years.

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Interventions

DIAGNOSTIC_TEST3-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).

DIAGNOSTIC_TESTFEES

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.

DIAGNOSTIC_TESTTracheal Ultrasound

Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation