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Aspiration in Acute Respiratory Failure Survivors 2

Primary Purpose

Dysphagia, Aspiration

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-Screenings Protocol
FEES
Tracheal Ultrasound
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniverityRecruiting
  • University of ColoradoRecruiting
  • Yale UniversityRecruiting
  • Boston UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Aspiration in Acute Respiratory Failure Survivors

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of participants experiencing non-silent aspiration
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.
Percentage of participants experiencing silent aspiration
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.
Percentage of participants experiencing post-extubation clinical laryngeal edema
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
Duration of mechanical ventilation
We will also collect the overall length of mechanical ventilation in days
Duration required for liberation from mechanical ventilation
We will also collect the overall length of the liberation process from mechanical ventilation in days

Full Information

First Posted
October 25, 2021
Last Updated
July 17, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05108896
Brief Title
Aspiration in Acute Respiratory Failure Survivors 2
Official Title
Aspiration in Acute Respiratory Failure Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Aspiration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center prospective single cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
855 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspiration in Acute Respiratory Failure Survivors
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
3-Screenings Protocol
Other Intervention Name(s)
Modified bedside swallow exam (BSE), Three Screening Tests
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
FEES
Other Intervention Name(s)
Fiberoptic Endoscopic Evaluation of Swallowing
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Tracheal Ultrasound
Intervention Description
Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation
Primary Outcome Measure Information:
Title
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
Description
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.
Time Frame
from extubation day 1 through hospital discharge, expected to be within 28 days
Secondary Outcome Measure Information:
Title
Percentage of participants experiencing non-silent aspiration
Description
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.
Time Frame
from extubation day 1 through hospital discharge, expected to be within 28 days
Title
Percentage of participants experiencing silent aspiration
Description
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.
Time Frame
from extubation day 1 through hospital discharge, expected to be within 28 days
Title
Percentage of participants experiencing post-extubation clinical laryngeal edema
Description
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
Time Frame
Within 24 hours after extubation
Title
Duration of mechanical ventilation
Description
We will also collect the overall length of mechanical ventilation in days
Time Frame
from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Title
Duration required for liberation from mechanical ventilation
Description
We will also collect the overall length of the liberation process from mechanical ventilation in days
Time Frame
from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to an ICU. Mechanical ventilation with an endotracheal tube for greater than 48 hours. Exclusion Criteria: Contraindication to enteral 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 72 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU). Extubated for greater than 72 hours. Inability to obtain informed consent from patient or an appropriate surrogate. Age < 18 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff McKeehan, RN,MSN
Phone
3037246080
Email
jeffrey.mckeehan@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Moss, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Univerity
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Levitt, MD, MS
Email
JLevitt@stanford.edu
First Name & Middle Initial & Last Name & Degree
Joseph Levitt, MD, MS
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Matheson, RN, BSN
Phone
303-724-6377
Email
anna.matheson@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey McKeehan, RN, MSN
Phone
3037246080
Email
Jeffrey.McKeehan@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Marc Moss, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Siner, MD
Email
Jonathan.Siner@yale.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Siner, MD
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gintas Krisciunas, MPH, MS
Email
Gintas.Krisciunas@bmc.org
First Name & Middle Initial & Last Name & Degree
Gintas Krisciunas, MPH, MS
First Name & Middle Initial & Last Name & Degree
Susan Langmore, PhD

12. IPD Sharing Statement

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