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Swallowing Assessment Protocols for Aspiration in Respiratory Failure Survivors
N/A
Recruiting
Led By Marc Moss, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mechanical ventilation with an endotracheal tube for greater than 48 hours
Admission to an ICU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Awards & highlights
Study Summary
This trial will study people who are very sick and need a machine to help them breathe, to see if there are problems with swallowing that could develop.
Who is the study for?
This trial is for adults who've been in the ICU and on a ventilator for over 48 hours. It's not suitable for those with uncontrolled bleeding, persistent delirium after extubation, neuromuscular disorders, chronic tracheostomy before ICU admission, head and neck cancer or surgery history, under 18s, prior swallowing issues or aspiration history.Check my eligibility
What is being tested?
The study tests three methods to understand swallowing problems post-acute respiratory failure: FEES (a type of swallow test), a protocol involving three screenings for swallowing safety, and tracheal ultrasound to assess airway management.See study design
What are the potential side effects?
Potential side effects may include discomfort from the procedures like sore throat from FEES or skin irritation from ultrasound gel. There might also be risks associated with sedation if used during these assessments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a breathing machine with a tube for more than 2 days.
Select...
I have been admitted to an intensive care unit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
Secondary outcome measures
Duration of mechanical ventilation
Duration required for liberation from mechanical ventilation
Percentage of participants experiencing non-silent aspiration
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Aspiration in Acute Respiratory Failure SurvivorsExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FEES
2013
N/A
~280
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,748 Previous Clinical Trials
2,163,111 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
583 Previous Clinical Trials
10,376,265 Total Patients Enrolled
Marc Moss, MDPrincipal InvestigatorUniversity of Colorado, Denver
6 Previous Clinical Trials
794 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a muscle or nerve disorder affecting my brain, spinal cord, or nerves.I have been on a breathing machine with a tube for more than 2 days.You have been breathing without a tube for more than 72 hours.I have had head or neck cancer or surgery in these areas.I cannot receive nutrition through my digestive tract.You have a permanent breathing tube in your throat that was put in before you went to the hospital.I have been admitted to an intensive care unit.I have a bleeding disorder causing uncontrolled nose or throat bleeding.I have been confused for over 72 hours after being taken off a ventilator.I have a history of swallowing difficulties or inhaling food/liquid into my lungs.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Aspiration in Acute Respiratory Failure Survivors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical trial for participants?
"Based on the information provided by clinicaltrials.gov, this trial is actively recruiting subjects. It was initially posted on December 15th 2021 and was most recently edited two days later."
Answered by AI
How many settings are being utilized for this experimental research?
"This research study has recruited participants from Yale University in New Haven, Connecticut; Stanford Univerity in Stanford, California; and Boston University in Boston, Massachusetts. Additionally, there are 4 other sites that are actively enrolling patients."
Answered by AI
What is the upper limit of individuals taking part in this trial?
"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was initially advertised on December 15th 2021, is currently seeking participants. 855 individuals are required between 4 specified sites for the study to be completed successfully."
Answered by AI
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