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CompletedNCT02450019NeuroVentORUpdated Nov 15, 2016

Protective Ventilation in Neurosurgery, a Pilot Study

An interventional study of Traditional to protective ventilation and Protective to traditional ventilation in Nervous System Neoplasms, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-15.

Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the detailed description

The role of mechanical ventilation in patients undergoing general anesthesia is worldwide well known but it has been associated with dangerous effects such as pulmonary complications, increasing postoperative morbidity and mortality. Lung-protective ventilation using low tidal volume and positive end-expiratory pressure (PEEP), can reduce morbidity and mortality in patients with acute respiratory distress syndrome and is now considered a strong recommendation in patients undergoing general anesthesia. At the moment there are no guidelines that define which kind of ventilation should be used.

Patients without acute lung injury are still ventilated with large -and perhaps too large- tidal volumes. A recent multicenter randomized controlled trial has concluded that the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization . A multicentre randomized controlled trial on mechanical ventilation during general anesthesia for open abdominal surgery has concluded that an intraoperative protective ventilation strategy should include a low tidal volume and low PEEP, without recruitment maneuvers. In 52 patients undergoing general anesthesia for open thoracic surgery lung protective ventilation was associated with better intraoperative and postoperative oxygenation, and shorter duration of postoperative mechanical ventilation from ICU admission to its withdrawal.

In conclusion protective ventilation, with low tidal volumes and low PEEP, seems to be the gold standard for intra-operative mechanical ventilation during general anesthesia.

Mechanical ventilation represents an important tool to obtain cerebral de-bulking during neurosurgery by maintaining moderate hypocapnia and positive intra-thoracic pressure the lowest possible. For these reasons the application of PEEP with high tidal volume has been historically seen as unfavourable by neuro-anesthesiologists and neurosurgeons fearing transmission to intracranial compartment of high venous pressure values with consequent brain swelling and eventually cerebral perfusion pressure reduction.

Nevertheless, recent studies suggested that in patients with traumatic brain injury (TBI) PEEP seems to be well tolerated without deleterious intracranial effect and its role in the context of a protective ventilation protocol associated with low tidal volume, so with low expected intra-thoracic pressures, has never been studied in patients undergoing to general anesthesia for intracranial surgery of neoplasms.

The traditional high-volume-no-PEEP ventilation strategy, called this way because it consists of an higher tidal volumes than protective ventilation and no PEEP, in neurosurgery should be compared with the recently proposed protective ventilation in order to eventually assess possible differences on respiratory and neurological outcomes. At this purpose a pilot study is needed to determine the effect size and variability of possible differences in dural tension between the two ventilation strategies.

Null hypothesis: Shifting from traditional ventilation protocol to a protective one during general anesthesia does not change levels of dural tension in patients undergone to elective neurosurgery for brain neoplasms.

To determine the effect size and variability of dural tension differences in patients undergoing intracranial neurosurgery and ventilated with either traditional or protective ventilation.

Mono-centric, double blind, 1:1 randomized, 2x2 crossover clinical trial. Patients will be randomized to receive either traditional or protective ventilation as the first ventilation. Randomization will be performed by a computer generated sequence. The results of the randomization will be transferred in sealed envelopes, one for each patient. When the patient will be randomized in the study, the envelop will be open and the piece of information about the randomization present in the envelop will be followed by the operating room anesthesiologist.

02

Conditions studied

  • Nervous System Neoplasms
03

In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

This study's enrollment of 40 is above the median of 35 across 379 interventional studies indexed under Nervous System Neoplasms.

Browse Nervous System Neoplasms studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (actual)

Study arms

  • Other
    Traditional to protective ventilation

    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

  • Other
    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). 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

  • ProcedureTraditional 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.

    Also known as: Traditional to protective

  • ProcedureProtective 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.

06

What researchers measure

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.

    Time frame: 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).

    Secondary endpoints: subjective assessment of dural tension by the attending neurosurgeon quantified as "acceptable tension" or "unacceptable tension" at the end of crossover.

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

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Study locations

1 site
  • S. Raffaele Hospital
    Milano, MI 20132, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02450019
Lead sponsor
IRCCS San Raffaele
Responsible party
Marco Gemma (MD Anaesthesist, IRCCS San Raffaele) — Principal investigator
First posted
May 21, 2015
Start date
May 2015
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Nov 15, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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