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Protective Ventilation in Neurosurgery, a Pilot Study

NCT02450019 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Nervous System Neoplasms

Interventions

PROCEDURE

Traditional to protective ventilation

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.

PROCEDURE

Protective to traditional ventilation

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Italy

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 NCT02450019 on ClinicalTrials.gov