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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT01539135
Eligibility Criteria:
Inclusion Criteria:
* Male or Female of all races
* Older than 18 years old
* Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
* Willing and able to give informed consent for participation in the study
* Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
* Expected hospital stay of greater than or equal to 23hrs
Exclusion Criteria:
* Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
* Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
* Surgical requirement for naso-tracheal intubation
* Patients undergoing surgical procedures directly on the lungs, trachea, or airways
* Presence of tracheostomy
* History of allergic reaction to methylene blue
* Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency
* Renal insufficiency or failure
* Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission
* Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time
* Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
* Patients younger than 18 years of age
* Prone positioning during surgery
* Pregnant or lactating women based on standardized preoperative screening protocols
* Legally detained prisoner status
* Unwilling or unable to give informed consent for participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01539135
Study Brief:
Protocol Section:
NCT01539135