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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04899856
Eligibility Criteria:
Inclusion Criteria:
1. Subject is undergoing an open cardiac procedure by median sternotomy
2. Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:
* Prior open cardiac surgery
* Left Ventricular Ejection Fraction (LVEF) ≤ 30%
* History of TIA or CVA
* Pre-operative or anticipated intraoperative intra-aortic balloon pump
* History of COPD
3. Subject is at least 22 years of age
4. Informed consent has been obtained from the patient
Exclusion Criteria:
1. Subject is on invasive mechanical ventilation prior to procedure
2. Subject has known or pre-existing phrenic nerve paralysis
3. Subject is having a left ventricular assist device implanted
4. Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
5. Subject is pregnant or lactating
6. Subject is actively participating in another clinical study which could affect outcomes in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04899856
Study Brief:
Protocol Section:
NCT04899856