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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT05859061
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
* Reasonable expectation to be extubated within 24 hours postop
Exclusion Criteria:
* Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy)
* Hemisternotomy approach
* History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy
* Preoperative use of opioids
* History of chronic pain or associated syndromes
* Concurrent Cox maze procedure
* Need for post-bypass mechanical circulatory support (ECMO, IABP) or open chest
* Women who are pregnant or breastfeeding
* Patients who are unable to consent for themselves
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05859061
Study Brief:
Protocol Section:
NCT05859061