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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT05073159
Eligibility Criteria:
Inclusion Criteria:
* • Ischemic stroke symptoms consistent with large artery occlusion
* Baseline non-contrast head CT (or MRI) negative for hemorrhage or mass- effect
* Evidence of arterial occlusion on standard of care CT angiography or MR angiography or NIHSS 10 or more points
* Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] \>6
* Patients treated with IV-tPA, mechanical thrombectomy or both
* Pre-stroke baseline modified Rankin Score (mRS) \<1
* Ability to enrol, randomize and begin the intervention within the Emergency Department
Exclusion Criteria:
* • Pregnancy or suspicion of pregnancy
* Evidence or suspicion of vomiting any time prior to consent which could predispose to aspiration pneumonia and therefore confound determination of protocol safety
* Evidence of evolving malignant infarction on admission noncontrast CT (or MRI)
* Need for intubation with mechanical ventilation, or non-invasive ventilatory support with either bi-level positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP)
* Inability to tolerate zero-degree positioning due to congestive heart failure, preexisting pneumonia, chronic obstructive pulmonary disease, or other medical condition
* Admission chest radiograph positive for pleural effusion, pulmonary edema, pneumonia, or other pulmonary condition that may confound determination of protocol safety
* Abnormal breath sounds on that may confound determination of protocol safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05073159
Study Brief:
Protocol Section:
NCT05073159