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:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02442102
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years old
* Required mechanical ventilation via an oral endotracheal tube
Exclusion Criteria:
* Unable to understand or speak English due to a language barrier
* Unable to understand or speak English due to a cognitive impairment
* Barium sulfate allergy
* Pregnancy
* Presence of any cardiac pacing device (including temporary epicardial pacing) without an underlying cardiac rhythm as confirmed by treating physician or diaphragmatic pacer
* Nasal endotracheal intubation during the present admission
* Patient is not expected to require ≥48 hours of intubation
* Pre-existing dysphagia/aspiration, voice or cognitive disorder
* Reflux with history of known or suspected aspiration
* Presence of a central nervous system, neuromuscular or connective tissue disease (e.g., stroke, Guillain-Barre, scleroderma)
* Active seizure disorder
* Pain disorder of the jaw muscles or mandibular joint
* Ever tracheotomy or prior endotracheal intubation other than for surgery (≤ 1 year)
* Head and/or neck disease (e.g., oropharyngeal cancer)
* Head and/or neck surgery other than tonsillectomy
* Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus
* Known or suspected sleep apnea (treated or untreated)
* Prior major thoracic surgery (e.g., sternotomy, thoracotomy)
* Unplanned (e.g., self- or accidental) extubation or re-intubation before consent
* Weight exceeds capacity of the radiology equipment
* Expected tracheostomy tube placement while in hospital
* Moribund (\>90% probability of mortality in hospital), based on ICU team's assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02442102
Study Brief:
Protocol Section:
NCT02442102