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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT05361850
Eligibility Criteria:
Inclusion Criteria:
* ASA physical status classification system for assessing the fitness of patients before surgery 1-3
* Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
* Adult patients age 18-64
* Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)
* Scheduled cases in which tracheal intubation and general anesthesia are indicated
Exclusion Criteria:
* Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
* Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)
* Full stomach
* Known difficult intubation or mask ventilation
* Surgeries of the airway and intrathoracic surgeries
* Emergent surgeries
* Case duration \>6 hours
* Pregnancy
* Patients scheduled to receive a protocolized anesthetic (Enhanced Recovery After Surgery aka ERAS)
* ASA Physical Status Classification 4 or 5
* Chronic diseases such as obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
* Uncontrolled gastroesophageal reflux disease (heartburn) defined by presence of symptoms despite compliance with appropriate medication regimen
* Patient scheduled to receive a protocolized anesthetic ie Enhanced Recovery After Anesthesia (ERAS)
* Surgeries requiring prone positioning
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05361850
Study Brief:
Protocol Section:
NCT05361850