Protective Ventilation in Neurosurgery, a Pilot Study (NeuroVentOR)

November 11, 2016 updated by: Marco Gemma, IRCCS San Raffaele
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • S. Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • Traditional to protective
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intracranial pressure measured in mmHg
Time Frame: Outcome 1 is assessed before the incision of dura mater (mean 1 hour).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dural tension measured by a two point scale (acceptable/unacceptable).
Time Frame: Outcome 2 is assessed before the incision of dura mater (mean 1 hour).
Secondary endpoints: subjective assessment of dural tension by the attending neurosurgeon quantified as "acceptable tension" or "unacceptable tension" at the end of crossover.
Outcome 2 is assessed before the incision of dura mater (mean 1 hour).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/INT/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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