Aspiration in Acute Respiratory Failure Survivors 2

Part of paid clinical trials in Stanford, California.

Sponsor
University of Colorado, Denver
Study ID
NCT05108896
Status
Recruiting
Apply to this trial

Conditions

  • Aspiration
  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Dec 15, 2021
Status verified
Oct 2024
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
855 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford UniverityStanfordCalifornia94305
Joseph Levitt, MD, MS
[email protected]
Joseph Levitt, MD, MS (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80045
Anna Matheson, RN, BSN
[email protected]
303-724-6377
Jeffrey McKeehan, RN, MSN
[email protected]
3037246080
Marc Moss, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519
Jonathan Siner, MD
[email protected]
Jonathan Siner, MD (PRINCIPAL_INVESTIGATOR)
Boston UniversityBostonMassachusetts02118
Gintas Krisciunas, MPH, MS
[email protected]
Gintas Krisciunas, MPH, MS (PRINCIPAL_INVESTIGATOR)
Susan Langmore, PhD (PRINCIPAL_INVESTIGATOR)
Tufts Medical CenterBostonMassachusetts02111
Nicholas Hill, MD
[email protected]
Nicholas Hill, MD (PRINCIPAL_INVESTIGATOR)

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