Aspiration in Acute Respiratory Failure Survivors 2

NCT05108896 | Recruiting DMC

• 2 other identifiers: 21-3873R01NR019989
• Study Type: interventional
• Target: 855
• Locations: 1 country
• Sites: 5

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.

Conditions

Dysphagia; Aspiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of participants experiencing non-silent aspiration

  from extubation day 1 through hospital discharge, expected to be within 28 days

• Percentage of participants experiencing silent aspiration

  from extubation day 1 through hospital discharge, expected to be within 28 days

• Percentage of participants experiencing post-extubation clinical laryngeal edema

  Within 24 hours after extubation

• Duration of mechanical ventilation

  from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average

• 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

Study Arms (1)

Aspiration in Acute Respiratory Failure Survivors

OTHER

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.

Diagnostic Test: 3-Screenings Protocol; Diagnostic Test: FEES; Diagnostic Test: Tracheal Ultrasound

Interventions

3-Screenings Protocol DIAGNOSTIC_TEST

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).

Also known as: Modified bedside swallow exam (BSE), Three Screening Tests

Aspiration in Acute Respiratory Failure Survivors

FEES DIAGNOSTIC_TEST

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.

Also known as: Fiberoptic Endoscopic Evaluation of Swallowing

Aspiration in Acute Respiratory Failure Survivors

Tracheal Ultrasound DIAGNOSTIC_TEST

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

Aspiration in Acute Respiratory Failure Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (5)

Stanford Univerity

Stanford, California, 94305, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Boston University

Boston, Massachusetts, 02118, United States

RECRUITING

Related Publications (112)

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MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Marc Moss, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff McKeehan, RN,MSN

CONTACT

3037246080; jeffrey.mckeehan@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center prospective single cohort study

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

US (5)