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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT01843933
Eligibility Criteria:
Inclusion:
* Pediatric patients (1-20yo) undergoing a scheduled, elective procedure at Yale-New Haven Hospital.
* An English-speaking parent or guardian must be present in the pre-operative care area in order to provide informed consent.
Exclusion:
* Currently or expected to receive post-operative assisted ventilation via an endotracheal tube (ex. major cardiac surgery) or tracheostomy
* Being directly admitted to the Pediatric Intensive Care Unit or pediatric ward instead of the PACU
* Undergoing urgent or emergent surgical procedures (i.e. non-elective) or surgery that will preclude the use of a nasal-oral cannula (ex. facial reconstruction)
* Any disease or state that may lead to abnormal ETCO2 values or baseline abnormalities in pulse oximetry. These would include evidence of active asthma exacerbation such as wheeze, diabetic ketoacidosis, moderate to severe dehydration, cardiac abnormalities, severe lung disease, and major trauma as the reason for surgery.
* Inability to tolerate the nasal-oral cannula, if it is removed during the study period by the patient or family, or if subjects cry continuously during the study, which inhibits accurate readings on the monitor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
20 Years
Study:
NCT01843933
Study Brief:
Protocol Section:
NCT01843933