Aspiration in Acute Respiratory Failure Survivors 2

May 1, 2024 updated by: University of Colorado, Denver

Aspiration in Acute Respiratory Failure Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

855

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Univerity
        • Contact:
        • Principal Investigator:
          • Joseph Levitt, MD, MS
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Jonathan Siner, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University
        • Contact:
        • Principal Investigator:
          • Gintas Krisciunas, MPH, MS
        • Principal Investigator:
          • Susan Langmore, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants experiencing non-silent aspiration
Time Frame: 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.
from extubation day 1 through hospital discharge, expected to be within 28 days
Percentage of participants experiencing silent aspiration
Time Frame: 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.
from extubation day 1 through hospital discharge, expected to be within 28 days
Percentage of participants experiencing post-extubation clinical laryngeal edema
Time Frame: 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
Within 24 hours after extubation
Duration of mechanical ventilation
Time Frame: 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
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
Time Frame: 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
from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Nursing Research (NINR)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-3873
  • R01NR019989 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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