Continuous intraoperative neuromonitoring (cIONM) of the facial nerve during surgery of the parotid gland

Not Applicable

Recruiting

• Conditions: D11.0; Parotid gland; C07; Malignant neoplasm of parotid gland

• Registration Number: DRKS00011051
• Lead Sponsor: HNO Klinik, SANA Kliniken Leipziger Land

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All patients older than 18 years of age, that undergo surgery of the parotid gland (partial or total) and provide written concent

Exclusion Criteria

- Revision surgery
- preoperative facial palsy
- Initial EMG Amplitude of the facial nerve < 500 µV
- Age < 18 years
- Patients with a cardial pacemaker
- Patients with a implanted defibrillator (ICD)
- Patients with heavy heart arrhythmias
- Pregnancy
- Epilepsy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of multiple combined Events (MCE) and loss of Signal (LOS) during cIONM with the grade of postoperative facial palsy

Secondary Outcome Measures

Name	Time	Method
Impact of compression, pressure, traction or thermal injury of the facial nerve on the EMG Signal<br><br>Safety of cIONM in the surgery of parotid gland<br><br>