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Aspiration in Acute Respiratory Failure Survivors 2

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05108896
Collaborator
National Institute of Nursing Research (NINR) (NIH)
855
Enrollment
4
Locations
1
Arm
48
Anticipated Duration (Months)
213.8
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 3-Screenings Protocol
  • Diagnostic Test: FEES
  • Diagnostic Test: Tracheal Ultrasound
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
855 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Multi-center prospective single cohort studyMulti-center prospective single cohort study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Aspiration in Acute Respiratory Failure Survivors
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Dec 15, 2025
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Diagnostic Test: 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).
Other Names:
  • Modified bedside swallow exam (BSE)
  • Three Screening Tests

    • Diagnostic Test: 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.
    Other Names:
  • Fiberoptic Endoscopic Evaluation of Swallowing

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Admission to an ICU.

    2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.

    Exclusion Criteria:

    1. Contraindication to enteral 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 72 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).

    8. Extubated for greater than 72 hours.

    9. Inability to obtain informed consent from patient or an appropriate surrogate.

    10. Age < 18 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Univerity Stanford California United States 94305
    2 University of Colorado Aurora Colorado United States 80045
    3 Yale University New Haven Connecticut United States 06519
    4 Boston University Boston Massachusetts United States 02118

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Marc Moss, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05108896
    Other Study ID Numbers:
    • 21-3873
    • R01NR019989
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Dec 20, 2021