NCT02450019

Brief Summary

The purpose of this study is to assess the effect size and variability of dural tension measured as intracranial pressure (ICP) below the dura of the surgical field in patients undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively ventilated with traditional high-volume-no-PEEP ventilation and protective low-volume-low-PEEP ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

May 9, 2015

Last Update Submit

November 11, 2016

Conditions

Nervous System Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Intracranial pressure measured in mmHg

    Primary endpoint: to assess the effect size and variability of dural tension measured as intracranial pressure (ICP) below the dura of the surgical field in patients undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively ventilated with traditional high-volume-no-PEEP ventilation and protective low-volume-low-PEEP ventilation.

    Outcome 1 is assessed before the incision of dura mater (mean 1 hour).

Secondary Outcomes (1)

  • Dural tension measured by a two point scale (acceptable/unacceptable).

    Outcome 2 is assessed before the incision of dura mater (mean 1 hour).

Study Arms (2)

Traditional to protective ventilation

OTHER

Traditional ventilation will be set with 9 ml/kg with predicted body weight of tidal volumes and no PEEP. Arterial CO2 partial pressure will be maintained between 30 and 35 mmHg. After intracranial pressure measurement ventilation will be switched to protective.

Procedure: Traditional to protective ventilation

Protective to traditional ventilation

OTHER

Protective ventilation will be set with 7 ml/kg tidal volume, 5 cm H2O PEEP, and 0.4 inspired O2 fraction (FiO2). Arterial CO2 partial pressure will be maintained between 30 and 35 mmHg. After intracranial pressure measurement ventilation will be switched to traditional.

Procedure: Protective to traditional ventilation

Interventions

Traditional to protective ventilationPROCEDURE

Traditional ventilation will be set with 9 ml/kg with predicted body weight of tidal volumes and no PEEP and switched to protective ventilation after intracranial pressure measurement.

Also known as: Traditional to protective
Traditional to protective ventilation
Protective to traditional ventilationPROCEDURE

Protective ventilation will be set with 7 ml/kg tidal volume, 5 cm H2O PEEP, and 0.4 inspired O2 fraction (FiO2), and switched to traditional ventilation after intracranial pressure measurement.

Protective to traditional ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective surgical removal of a supra-tentorial neoplasm conditioning mass effect defined as:
  • Median line shift at preoperative CT scan ≥ 5mm
  • Cortical brain effacement at preoperative CT scan

You may not qualify if:

  • Age \< 18 yrs or \> 80 yrs.
  • BMI \> 30
  • Pregnancy.
  • Refusal to sign the informed consent.
  • Emergency surgery.
  • Respiratory co-morbidities (clinical evidence or history of COPD, asthma, interstitial pneumopathies, previous thoracic surgery).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Raffaele Hospital

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Anaesthesist

Study Record Dates

First Submitted

May 9, 2015

First Posted

May 21, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

IT(1)