Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT01011803
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients admitted to the ICU, deemed at risk for aspiration, who require FEES and MBS per speech therapy evaluation.
2. Ability to follow commands, read English language, vocalize and complete a predefined phonation test and the DAST.
3. Patients are able to undergo formal swallow evaluation by FEES and/or MBS.
Exclusion Criteria:
1. Patients who have had any type of head and neck surgery.
2. Patients that cannot read or talk, or speak/understand English language.
3. Patients with delirium, disorientation, unable to follow commands.
4. Patients with gastric tubes, tracheostomy or strict order for nothing by mouth.
5. Coagulation disorder that is prohibitive for FEES (platelets \<50, 000, ongoing or uncontrolled bleeding, international normalized ratio (INR)\> 1.5, activated partial thromboplastin time (aPTT) greater than 1.5 times normal value).
6. Patients that cannot sit up at 90 degrees for MBS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01011803
Study Brief:
Protocol Section:
NCT01011803