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Neurosurgery Recruitment Maneuver Study

Primary Purpose

Subdural Pressure During Supratentorial Brain Tumour Resection

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Recruitment maneuver
Sham recruitment maneuver
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subdural Pressure During Supratentorial Brain Tumour Resection focused on measuring Supratentorial neurosurgery, Recruitment maneuver, Subdural pressure, Brain relaxation, Cerebral perfusion pressure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (greater than 18 years of age) scheduled for craniotomy for resection of a supratentorial brain tumour who are American Society of Anesthesiologist's class I to III are eligible to participate.

Exclusion Criteria:

  • Patient with altered level of consciousness or unstable/deteriorating neurologic status preoperatively will be excluded.
  • In addition, if the neurosurgeon considers the mass effect too great to safely participate the patient will be excluded. Baseline subdural pressure will be measured prior to randomization
  • Patients with a subdural pressure greater than 20 mmHg will be excluded.
  • Other exclusion criteria include significant cardiac disease (e.g. ejection fraction < 40 percent, significant valvular disease, pulmonary hypertension), sepsis, hypovolemia and prior lung resection or history of pneumothorax.

Sites / Locations

  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Recruitment maneuver

Sham recruitment maneuver

Arm Description

The recruitment maneuver will involve application of continuous positive airway pressure of 30 cm of water for 30 seconds.

The sham recruitment maneuver will involve application of continuous positive airway pressure of 5 cm of water for 30 seconds.

Outcomes

Primary Outcome Measures

Subdural pressure
Change in subdural pressure (mmHg) during a recruitment maneuver as compared to a sham recruitment maneuver

Secondary Outcome Measures

Brain relaxation score
Change in surgeon-assessed brain relaxation score (1-4) at the end of the recruitment maneuver as compared to the sham recruitment maneuver
Cerebral perfusion pressure
Change in cerebral perfusion pressure at the end of the recruitment maneuver as compared to the sham recruitment maneuver

Full Information

First Posted
March 13, 2014
Last Updated
May 1, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02093117
Brief Title
Neurosurgery Recruitment Maneuver Study
Official Title
Effect of an Alveolar Recruitment Maneuver on Subdural Pressure, Brain Swelling and Cerebral Perfusion Pressure in Patients Undergoing Supratentorial Tumour Resection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background. Patients undergoing neurosurgical procedures experience higher rates of postoperative respiratory failure compared to the broader surgical population. Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be beneficial. Despite this potential benefit, the effect of high levels of continuous airway pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined prior to applying this intervention to the neurosurgical population. Objectives. The primary objective is to determine the effect of an alveolar recruitment maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1) brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial tumour resection. Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in subdural pressure. Methods. This single center, randomized, cross-over study will enroll 30 American Society of Anesthesiologists Classification I-III patients scheduled to undergo supratentorial brain tumour resection at Vancouver General Hospital. All patients will receive a standardized general anesthetic including invasive blood pressure monitoring. After removal of the bone flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain bulk will be assessed using a validated 4-point scale. After baseline arterial and subdural pressure determination and brain swelling assessments, patients will be randomized to receive either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment maneuver of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum mean arterial pressure during the maneuver will be noted, and the neurosurgeon will be asked to score the brain bulk. After a 2-minute equilibration period, the protocol will be repeated with the alternate group allocation. Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural pressure), determined that a sample size of 22 patients would allow us to detect a difference of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error of 0.2 and two-sided significance testing. The subdural pressure during the recruitment maneuver as compared to the sham maneuver will be analyzed using a paired t-test. The brain bulk score will be compared using a Wilcoxon signed rank test. All data analysis will be performed with STATA 12.1 (StataCorp, College Station, TX).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdural Pressure During Supratentorial Brain Tumour Resection
Keywords
Supratentorial neurosurgery, Recruitment maneuver, Subdural pressure, Brain relaxation, Cerebral perfusion pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recruitment maneuver
Arm Type
Experimental
Arm Description
The recruitment maneuver will involve application of continuous positive airway pressure of 30 cm of water for 30 seconds.
Arm Title
Sham recruitment maneuver
Arm Type
Sham Comparator
Arm Description
The sham recruitment maneuver will involve application of continuous positive airway pressure of 5 cm of water for 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
Recruitment maneuver
Intervention Description
continuous positive airway pressure of 30 cm of water for 30 seconds
Intervention Type
Procedure
Intervention Name(s)
Sham recruitment maneuver
Intervention Description
Continuous positive airway pressure of 5 cm of water for 30 seconds
Primary Outcome Measure Information:
Title
Subdural pressure
Description
Change in subdural pressure (mmHg) during a recruitment maneuver as compared to a sham recruitment maneuver
Time Frame
At baseline and within 30 seconds of recruitment maneuver or sham
Secondary Outcome Measure Information:
Title
Brain relaxation score
Description
Change in surgeon-assessed brain relaxation score (1-4) at the end of the recruitment maneuver as compared to the sham recruitment maneuver
Time Frame
At baseline and within 30 seconds of recruitment maneuver or sham
Title
Cerebral perfusion pressure
Description
Change in cerebral perfusion pressure at the end of the recruitment maneuver as compared to the sham recruitment maneuver
Time Frame
At baseline and within 30 seconds of recruitment maneuver or sham

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (greater than 18 years of age) scheduled for craniotomy for resection of a supratentorial brain tumour who are American Society of Anesthesiologist's class I to III are eligible to participate. Exclusion Criteria: Patient with altered level of consciousness or unstable/deteriorating neurologic status preoperatively will be excluded. In addition, if the neurosurgeon considers the mass effect too great to safely participate the patient will be excluded. Baseline subdural pressure will be measured prior to randomization Patients with a subdural pressure greater than 20 mmHg will be excluded. Other exclusion criteria include significant cardiac disease (e.g. ejection fraction < 40 percent, significant valvular disease, pulmonary hypertension), sepsis, hypovolemia and prior lung resection or history of pneumothorax.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Flexman, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28342045
Citation
Flexman AM, Gooderham PA, Griesdale DE, Argue R, Toyota B. Effects of an alveolar recruitment maneuver on subdural pressure, brain swelling, and mean arterial pressure in patients undergoing supratentorial tumour resection: a randomized crossover study. Can J Anaesth. 2017 Jun;64(6):626-633. doi: 10.1007/s12630-017-0863-7. Epub 2017 Mar 24.
Results Reference
derived

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Neurosurgery Recruitment Maneuver Study

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