Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients

NCT02507999 | Completed

• 1 other identifier: GDT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Goal directed therapy (GDT) is a technique, which employs a non-invasive cardiac output monitoring (NICOM) device to guide management of circulating blood volume and blood pressure during procedures. The purpose of this study is to determine whether the use of goal-directed therapy to optimize blood volume and cardiac output during the procedure can improve the outcome of patients undergoing endovascular treatment of a brain aneurysm.

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• Composite outcomes of cerebral vasospasm, stroke and death

  To determine if the use of the Flotrac device during surgery is able to decrease the morbidity and mortality rates for 30 days following surgery

  30 days

Secondary Outcomes (3)

• Composite outcomes of all perioperative complications

  7 days, 30 days, 90 days

• Neurological outcomes

  7 days, 30 days, 90 days

• Length of hospital stay

  From study entry until hospital discharge, or up to 90 days of after the procedure

Study Arms (2)

Goal Directed Therapy - Flotrac Use Arm

EXPERIMENTAL

This arm will employ the use of the Flotrac device to monitor cardiac output, cardiac index, stroke volume, stroke volume variation, and blood pressure management.

Device: Flotrac

Non-Goal Directed Therapy

NO INTERVENTION

In this arm, patients will have the Flotrac machine attached to their arterial catheter but the screen that displays the monitor readings will be covered and machine alarms will be turned off. The anesthesiologist will not be aware of the Flotrac monitor readings.

Interventions

Flotrac DEVICE

Flotrac guided intervention

Goal Directed Therapy - Flotrac Use Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients (age\> 18 years of age) scheduled for aneurysm endovascular coiling procedures over the next 2 years.
• Grade I to IV SAH within 5 days of presentation will be included in the study.
• Only patients identified as appropriate by the neurosurgeon/neuro-radiologist will be recruited.

You may not qualify if:

• \- Patients with un-ruptured aneurysm(s)
• Patients with previous clipping or coiling procedure for the same aneurysm.
• Patients undergoing concomitant extracranial-intracranial bypass procedures or other non-neurosurgical procedures.
• Patients with giant aneurysm (size\> 25mm)
• Pediatric patients (\<18 years of age) or pregnant patients
• Unable to obtain informed consent from patients or substitute decision maker (SDM).

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Science Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jason Chui, MBChB

  Assistant Professor, Western Unviersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthetist

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 24, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)