Nervous System NeoplasmsNeuroVentORNCT02450019
Protective Ventilation in Neurosurgery, a Pilot Study
A study testing Traditional to protective ventilation and Protective to traditional ventilation in people with Nervous System Neoplasms, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nervous System Neoplasms
- What is being tested?
- Traditional to protective ventilation and Protective to traditional ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nervous System Neoplasms
- Being tested
- Traditional to protective ventilation, Protective to traditional ventilation
- Medical subject headings
- Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional to protective ventilationProcedure or surgery
Also called Traditional to protective
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.
Protective to traditional ventilationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Protective to traditional ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Outcome 2 is assessed before the incision of dura mater (mean 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Gemma, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450019
- Sponsor's protocol ID
- 22/INT/2015
- Acronym
- NeuroVentOR
- Status last verified
- Nov 2016
- First submitted
- 9 May 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Ventilation in Neurosurgery, a Pilot Study
- ClinicalTrials.gov ID
- NCT02450019
- Acronym / sponsor ID
- NeuroVentOR / 22/INT/2015
- Conditions
- Nervous System Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional to protective ventilation | Other | Procedure: Traditional to protective ventilationTraditional 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. |
| Protective to traditional ventilation | Other | Procedure: Protective to traditional ventilationProtective 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Age < 18 yrs or > 80 yrs.
- BMI > 30
- Pregnancy.
- Refusal to sign the informed consent.
- Emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional to protective ventilationAlso: Traditional to protectiveTraditional 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 or surgery | Traditional to protective ventilation |
| Protective to traditional ventilationProtective 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. | Procedure or surgery | Protective to traditional ventilation |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional to protective ventilation and Protective to traditional ventilation in people with Nervous System Neoplasms, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial pressure measured in mmHg (time frame: Outcome 1 is assessed before the incision of dura mater (mean 1 hour).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.