Trial document




drksid header

  DRKS00011051

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

cIONM in parotis surgery

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://-

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Incidence of postoperative permanent facial paralysis remains relatively high at 4-7%, despite the use of intraoperative neuromonitoring. The majority of the paresis occur although the nerve is intraoperatively often described as anatomically intact. Therefore intraoperative sprains and strains of the nerve apparently play a crucial role for postoperative nerve function.
In recent years, the functionality of IONM has been enriched with the introduction of continuous intraoperative neuromonitoring (cIONM). cIONM provides constant impulse to the nerve, with continuous registration of response potentials. Here are even the smallest potential changes through manipulation are visible and postoperative nerve function may already be intraoperatively predicted regarding amplitude recovery . The advantages of a cIONM compared to a conventional, intermittent IONM have already been demonstrated in the surgery of the thyroid gland in terms of postoperative nerve function.
Therefore, we aim to show what is the predictive value in terms of postoperative facial paralysis using cIONM of the facial nerve in the parotid surgery and whether the intraoperatively verified signal changes may be correlated with the degree of paralysis . Should this be the case, threatening malfunction of the nerve can already be detected intraoperatively and thus avoided by modifying the surgical procedure in the future.
The surgical technique used in our proposed study is established and practiced in our hospital for many years to current indications. In addition, a saxophone electrode for cIONM on the truck of the facial nerve for continuous stimulation will be placed. There are thereby no new medical products or other medications used.
The safety of cIONM been proven in various publications for use in thyroid surgery.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Incidence of postoperative permanent facial paralysis remains relatively high at 4-7%, despite the use of IONM. The majority of the paresis occur although the nerve is intraoperatively often described as anatomically intact. Therefore intraoperative sprains and strains of the nerve apparently play a crucial role for postoperative nerve function.
In recent years, the functionality of IONM has been enriched with the introduction of continuous intraoperative neuromonitoring (cIONM). cIONM provides constant impulse to the nerve, with continuous registration of response potentials. Here are even the smallest potential changes through Manipulation are visible and postoperative nerve function may already be intraoperatively predicted regarding amplitude recovery . The advantages of a cIONM compared to a conventional, intermittent IONM have already been demonstrated in the surgery of the thyroid gland in terms of postoperative nerve function.
Therefore, we aim to show what is the predictive value in terms of postoperative facial paralysis using cIONM of the facial nerve in the parotid and whether the intraoperatively verified signal changes may be correlated with the degree of paralysis . Should this be the case, threatening malfunction of the nerve can already be detected intraoperatively and thus avoided by modifying the surgical procedure in the future.
The surgical technique used in our proposed study is established and practiced in our hospital for many years to current indications. In addition, a saxophone electrode for cIONM on the truck of the facial nerve for continuous stimulation will be placed. There are thereby no new medical products or other medications used.
The safety of cIONM been proven in various publications for use in thyroid surgery. Neither changes in the amplitude or latency for neuronal stimulation nor cardiac, pulmonary or gastrointestinal side effects were detected.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011051
  •   2016/09/28
  •   [---]*
  •   yes
  •   Approved
  •   EK-BR-53/16-1, Ethikkommission bei der Sächsischen Landesärztekammer
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   D11.0 -  Benign neoplasm: Parotid gland
  •   C07 -  Malignant neoplasm of parotid gland
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The indentification of the facial nerve trunk as it leaves the stylomastoid foramen is made during the operation using IONM (needle electrodes, 4-Channel R. frontalis, R. orbicularis occuli, R. zygomaticus, R. orbicularis oris, System: Avalanche® XT, Dr. Langer Medical GmbH, 79183 Waldkirch, Germany). The next step is the preparation of the facial nerve until pes anserinus and placing the Saxophone electrode ® (Dr. Langer Medical GmbH, 79183 Waldkirch) after undermining the facial nerve trunk. It comes to no significant additional time loss or enhanced manipulation. The electrode is made of sterilizable silicone which enables an atraumatic adhesion. Then the trunk is stimulated with an ascending threshold starting from 0.1 mA in 0.1mA increments up to the point at which the amplitude of the EMGs reaches a plateau (supramaximal threshold - smS). The goal is to avoid unnecessary Exhaustion taking the individual differences of patients into account. The upper limit of smS is defined as 1 mA. Continuous stimulation of the facial nerve trunk takes place with a pulse width of 200 us, a pulse rate of 3 / s and the smS described above (mA).
    The operation of the parotid gland follows in the customary manner. During the preparation of parotid tissue all MKE and SV are continuously documented.
    There is neither extension of the operating times nor extensive preparation of the nerve trunk as usual.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Impact of compression, pressure, traction or thermal injury of the facial nerve on the EMG Signal

Safety of cIONM in the surgery of parotid gland

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/10/06
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.