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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02038894
Eligibility Criteria:
Inclusion Criteria:
* Patient presenting as out-patients, scheduled to receive an anesthetic for a diagnostic EGD
* Patient must be a candidate for any of the three anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology, who is not a member of the study team and will be responsible for obtaining consent for anesthesia
* Patient must be between ages 1 and 12 years (inclusive)
* Patient must be American Society of Anesthesiology (ASA) class I or II;
* Eosinophilic esophagitis (EE) patients classified as an ASA III status for their EE diagnosis only
* Patient must have fasted according to CCHMC policy
* Patient's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate
Exclusion Criteria:
* Patients less than a year old and greater than 12 years old
* Patients undergoing therapeutic upper endoscopy
* Patients with an ASA physical status III or greater (other than EE patients)
* Patients with history of allergy to propofol, any other drug in the protocol, or eggs (exclusive of egg allergies identified only by skin testing or manifested only by gastrointestinal symptoms)
* Patients with personal or family history of malignant hyperthermia
* Obese patients (Body mass index more than 95th percentile for age)
* Patients with significant airway abnormalities (e.g., trisomy 21, craniofacial syndromes, sub-glottic stenosis, tracheomalacia, tracheostomy)
* Patients with history of obstructive sleep apnea
* Patient receiving sedative premedication
* Patient previously treated under this protocol
* Patients with symptoms of an active upper respiratory infection
* Patients with history of coagulopathy
* Patients with esophageal varices or gastrointestinal bleeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
12 Years
Study:
NCT02038894
Study Brief:
Protocol Section:
NCT02038894