Patient Experiences of IONM and Outcomes

NCT04443465 | Unknown

• 1 other identifier: IRAS 239002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Experiences of participants who undergo intra-operative neurophysiological monitoring under anaesthesia

  A qualitative study of patient experiences by thematic analysis

  2 years

Secondary Outcomes (3)

• IONM related postoperative sequel during post surgical recovery in hospital

  2 years

• Mortality at 28 day and 1 year follow up

  2 years

• Morbidity at 28 days and 1 year follow up

  2 years

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children aged 10 and above undergoing brain or spinal surgery with intra operative neurophysiological monitoring with intravenous anaesthesia

You may qualify if:

• All patients aged 10 and above undergoing elective neurosurgery guided by IONM will be recruited with informed consent.

You may not qualify if:

• Lack of informed consent and who are unable to communicate verbally.-

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Kings College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (7)

• Stecker MM. A review of intraoperative monitoring for spinal surgery. Surg Neurol Int. 2012;3(Suppl 3):S174-87. doi: 10.4103/2152-7806.98579. Epub 2012 Jul 17.

  PMID: 22905324 BACKGROUND

• Jameson LC, Sloan TB. Monitoring of the brain and spinal cord. Anesthesiol Clin. 2006 Dec;24(4):777-91. doi: 10.1016/j.atc.2006.08.002.

  PMID: 17342964 BACKGROUND

• Arnold PM. Use of intraoperative monitoring in children. J Neurosurg Pediatr. 2014 Jun;13(6):589. doi: 10.3171/2013.9.PEDS13439. Epub 2014 Apr 4. No abstract available.

  PMID: 24702618 BACKGROUND

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

• Jameson LC, Janik DJ, Sloan TB. Electrophysiologic monitoring in neurosurgery. Anesthesiol Clin. 2007 Sep;25(3):605-30, x. doi: 10.1016/j.anclin.2007.05.004.

  PMID: 17884710 RESULT

• Soghomonyan S, Moran KR, Sandhu GS, Bergese SD. Anesthesia and evoked responses in neurosurgery. Front Pharmacol. 2014 Apr 14;5:74. doi: 10.3389/fphar.2014.00074. eCollection 2014. No abstract available.

  PMID: 24782777 RESULT

• Cabraja M, Stockhammer F, Mularski S, Suess O, Kombos T, Vajkoczy P. Neurophysiological intraoperative monitoring in neurosurgery: aid or handicap? An international survey. Neurosurg Focus. 2009 Oct;27(4):E2. doi: 10.3171/2009.7.FOCUS0969.

  PMID: 19795951 RESULT

MeSH Terms

Conditions

Intraoperative Complications; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chulananda Goonasekera, PhD

  Kings College Hospital NHS Trust, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: June 23, 2020
• Study Start: October 10, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-03

Locations

GB (1)