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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

Must not have

Pre-existing or acute primary central or peripheral neuromuscular disorder

Pre-existing head and neck cancer or surgery

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

No Placebo-Only Group

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.

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.

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 below

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I have been on a breathing machine with a tube for more than 2 days.

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I have been admitted to an intensive care unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a muscle or nerve disorder affecting my brain, spinal cord, or nerves.

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I have had head or neck cancer or surgery in these areas.

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I cannot receive nutrition through my digestive tract.

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I have a bleeding disorder causing uncontrolled nose or throat bleeding.

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I have been confused for over 72 hours after being taken off a ventilator.

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I have a history of swallowing difficulties or inhaling food/liquid into my lungs.

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I am under 18 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies

Secondary study objectives

Duration of mechanical ventilation

Duration required for liberation from mechanical ventilation

Percentage of participants experiencing non-silent aspiration

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 9Eligibility criteria met