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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01906060
Eligibility Criteria:
Inclusion criteria:
* elective surgery requiring tracheal intubation using an oral tracheal tube
* anticipated extubation in the operating room
* American Society of Anaesthesiologist Physical Status 1-3
* age = 18 years and = 85 years
* oral and written informed consent
* weight = 100kg (according to the product description)
* ability to understand the study information
Exclusion criteria:
* pharyngeal, laryngeal or tracheal pathology, including tracheostomy
* mouth opening \< 2.5 cm
* any form of airway infection such as upper-respiratory tract infection, pneumonia or suspected tuberculosis
* any disease that might impair the power of judgement (psychiatric disease, dementia)
* indicated rapid sequence induction which is a standard when high risk for regurgitation and/or aspiration is present
* the subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
* pregnancy
* breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01906060
Study Brief:
Protocol Section:
NCT01906060