Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to test if a non-invasive patch can safely monitor facial nerve activity in adults during parotid or facial surgery. Monitoring the facial nerve during these surgeries helps lower the risk of nerve injury and possible functional and aesthetic damage. Current methods use small needles and require careful placement, which can be difficult and may affect how well they work.
The aims to answer the following questions:
The research team will compare the readings from the patch with those from the standard method used during surgery.
Participants will:
All the decisions during surgery will be based only on the standard method.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Facial Nerve Monitoring | Experimental | Participants will undergo intraoperative facial nerve monitoring using the standard monitoring method along with a non-invasive patch applied to the face. Both methods will be used during the same surgery for all participants, and clinical decisions will be based solely on the standard monitoring method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive facial nerve monitoring patch | Device | A non-invasive surface electrode patch applied to the face to continuously monitor facial nerve activity during surgery. The patch uses dry electrodes to detect electrical signals associated with nerve stimulation and muscle activity. Data are recorded throughout the procedure for analysis. The patch operates in parallel with the standard monitoring method and does not influence clinical decision making. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between the patch and the standard monitoring tool in detecting facial nerve activity | Agreement between the non-invasive patch and the standard monitoring method in detecting facial nerve activity during surgery. Agreement evaluation will be based on concordance in detection and temporal correlation of nerve responses recorded by both methods during intraoperative stimulation. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of non-invasive patch use | Evaluation of device-related adverse effects associated with the use of the non-invasive facial nerve monitoring patch during surgery, including skin reactions or other local adverse effects. | During surgery |
| Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010307 | Parotid Neoplasms |
| D019066 | Facies |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Subjective assessment regarding the usability and integration of the patch during surgery |
| During surgery |
| D009369 |
| Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |