Understanding swallowing problems in patients recovering from respiratory failure

Aspiration in Acute Respiratory Failure Survivors

This study is testing how common swallowing problems are in patients recovering from respiratory failure after being on a ventilator, to find better ways to spot and manage these issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 855 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Colorado, Denver (other)
• Locations: 5 sites (Stanford, California and 4 other locations)
• Trial ID: NCT05108896 on ClinicalTrials.gov

What this trial studies

This study aims to investigate swallowing difficulties that may arise in patients who have been on mechanical ventilation due to severe respiratory failure. It focuses on post-extubation dysphagia (PED), a condition where patients struggle to swallow after the removal of an endotracheal tube. The study will assess the frequency and detection methods of PED by observing patients swallowing with and without the aid of a small camera. The goal is to improve detection and management of this serious condition to prevent further complications.

Who should consider this trial

Good fit: Ideal candidates are adults who have been admitted to an ICU and required mechanical ventilation with an endotracheal tube for more than 48 hours.

Not a fit: Patients with pre-existing dysphagia, neuromuscular disorders, or those who have been extubated for more than 96 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better detection and management of swallowing difficulties in critically ill patients, reducing the risk of aspiration and associated lung problems.

How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated that understanding and addressing dysphagia in critically ill patients is crucial for improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

1. Admission to an ICU.
2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.

Exclusion Criteria:

1. Likely persistent contraindications to enteral/oral 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 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
8. Extubated for greater than 96 hours.
9. Inability to obtain informed consent from patient or an appropriate surrogate.
10. Age \< 18 years.

Where this trial is running

Stanford, California and 4 other locations

• Stanford Univerity — Stanford, California, United States (RECRUITING)
• University of Colorado — Aurora, Colorado, United States (RECRUITING)
• Yale University — New Haven, Connecticut, United States (RECRUITING)
• Tufts Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Boston University — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Marc Moss, MD — University of Colorado, Denver
• Study coordinator: Jeff McKeehan, RN,MSN

Conditions: Dysphagia, Aspiration