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Patient Experiences of IONM and Outcomes

NCT04443465 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-06-23

No results posted yet for this study

Summary

Resection of brain tumours forms a large proportion of work in brain surgery. One important aspect is to minimize damage to normal brain structures during this process. This improves patient outcomes and reduces complications. To identify normal brain structures from the abnormal tumours, the brain surgeons use a 'guidance' technique called intraoperative neuro-monitoring (IONM).

IONM uses various electrodes to observe spontaneous electrical activity of the brain or its reaction to a stimulus such as muscle contraction, light or sound. It is now becoming common practice for neurosurgeons to use this tool during brain and spinal surgery to provide a real-time feedback under anaesthesia to help them minimise injury to important and normal brain and spine structures.

IONM interpretation needs fulfilment of multiple preconditions and major modifications to the anaesthetic to reduce its inaccuracies. This invites added risks and complications such as awareness, convulsions and heart problems under anaesthesia. A team approach between the surgeon, anaesthetist and neurophysiologist (IONM specialist) is also crucial to obtain meaningful results. Therefore, the usefulness of this technique is still not perfect.

Although, benefits of IONM are obvious, information on associated complications and patient experience are not commonly found in the literature. Information on other effects such as hormonal balance and tumour recurrence are also scarce. In general, these aspects have little scientific exploration.

There are anecdotal reports of recurrent seizures during IONM leading to serious heart problems, teeth and tongue damage due to grinding and postoperative calf muscle injury necessitating further surgery to save limbs. Neither of these is in the literature including unorthodox treatments such as the use of cold saline to control IONM triggered fits.

This study is designed to observe complications and outcome and explore patient experiences following IONM in an observational capacity not interfering with the clinical management or treatment of these patients. The investigators intend to interview the participants after surgery, at a convenient time before leaving hospital to understand their views and experiences during and after surgery and their general progress in the following one year.

Conditions

  • Intraoperative Neurophysiological Monitoring
  • Complication
  • Intraoperative Complications
  • Postoperative Complications

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Chulananda Goonasekera, PhD · Kings College Hospital NHS Trust, London

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2020-03-10
Completion
2021-03-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04443465 on ClinicalTrials.gov