Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05108896

Conditions

Dysphagia

Aspiration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3-Screenings Protocol

FEES

Tracheal Ultrasound

Study Details

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

Study ID

NCT05108896

Start date

Dec 15, 2021

Status verified date

Oct, 2024

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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.

Study Design

Enrollment

855 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Aspiration in Acute Respiratory Failure Survivors

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.

Interventions

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

Primary outcome measure

  • Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies [ Time Frame: from extubation day 1 through hospital discharge, expected to be within 28 days ]

Central Contacts and Locations

Central contacts

Jeff McKeehan, RN,MSN

3037246080jeffrey.mckeehan@cuanschutz.edu

Locations

Stanford Univerity

Recruiting

Stanford, California, United States, 94305

Contacts

Joseph Levitt, MD, MS

JLevitt@stanford.edu

Principal Investigator:

Joseph Levitt, MD, MS

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Anna Matheson, RN, BSN

303-724-6377anna.matheson@cuanschutz.edu

Jeffrey McKeehan, RN, MSN

3037246080Jeffrey.McKeehan@cuanschutz.edu

Principal Investigator:

Marc Moss, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Jonathan Siner, MD

Jonathan.Siner@yale.edu

Principal Investigator:

Jonathan Siner, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Nicholas Hill, MD

nicholas.hill@tuftsmedicine.org

Principal Investigator:

Nicholas Hill, MD

Boston University

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Gintas Krisciunas, MPH, MS

Gintas.Krisciunas@bmc.org

Principal Investigator:

Gintas Krisciunas, MPH, MS

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-10-08.