N/A
N=248
Aspiration in Acute Respiratory Failure Survivors
Dysphagia
Bottom Line
View on ClinicalTrials.gov: NCT02363686 ↗Enrolled (actual)
248
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Participants Experiencing Aspiration — 70; 52 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FEES (Procedure); BSE (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Aspiration |
70; 52 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects will be eligible to participate in the study if they meet all of the following criteria:
- Admission to a University of Colorado Hospital ICU
- Mechanical ventilation support through an endotracheal tube for greater than 24 hours
Exclusion Criteria
- Subjects will be ineligible to participate in the study if they meet any of the following criteria
- Age less than 18 years
- Contraindication to enteral nutrition administration
- Diagnosis of an acute or pre-existing central nervous system disorder (excluding a seizure disorder)
- Pre-existing dysphagia
- Previous surgery of the head, neck, or esophagus
- Previous cancer of the head or neck
- The presence of a tracheostomy
- The presence of nasal or pharyngeal trauma or bleeding
- Clinical team believes one of the protocols would be harmful to an individual patient
- Expected survival less than 3 months
- Pregnancy
- Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the followup period
- Inability to give informed consent and proxy unavailable.
Data sourced from ClinicalTrials.gov (NCT02363686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.