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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT06823661
Eligibility Criteria:
Inclusion Criteria:
* Males and females at least 18 years old
* Adults undergoing an elective (General, Plastics, Urology, Gynecologic Oncology, Vascular, Otolaryngology, Transplant) surgery with general anesthesia who are recovering in the PACU
* American Society of Anesthesiologists (ASA) grade I-IV
* Scheduled to be seen at the Pre-Admission Clinic or Surgery Inpatient Unit
* Able to complete questionnaires with or without assistance
* Able to understand the study protocol, its requirements, risks, and discomforts
* Able to provide written informed consent
Exclusion Criteria:
* A) Preoperative exclusion criteria:
* American Society of Anesthesiologists (ASA) grade V-VI
* Urgent or emergent surgical procedures that there is insufficient time prior to anticipated commencement of the procedure for participation in the study
* Patients with implantable medical electronic devices (eg, pacemaker, implantable cardioverter defibrillator, catheter, and so on.)
* Patients with febrile illnesses or acute infectious diseases
* Pregnancy
* Epilepsy.
* B) Postoperative exclusion criteria:
* Surgery that would preclude the use of a nasal cannula or face mask used for capnography monitoring (e.g., facial reconstruction)
* Postoperative mental status precludes application of study equipment, including a nasal cannula/face mask and/or the stimulation pads (e.g., delirium or agitation during recovering from anesthesia, repeated removal of cannula)
* Postoperative admission to the ICU or any site other than the PACU
* Need for postoperative assisted ventilation via an endotracheal tube or tracheostomy
* An abnormal respiratory tract identified during or immediately after surgery can lead to severe respiratory obstruction
* Patients with cardiac arrhythmia (history of atrial fibrillation or bundle branch block)
* Skin conditions such as open sores preventing proper application of electrodes
* Presence of metal implants in both arms
* Lack of access to upper extremities following surgery for application of the stimulation pads
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06823661
Study Brief:
Protocol Section:
NCT06823661