Clinical trial · Interventional
Protective Ventilation in Neurosurgery, a Pilot Study
NCT02450019CI-TRIAL-00024806NeuroVentORcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nervous System Neoplasms | Nervous System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protective to traditional ventilation | Procedure | — | UNRESOLVED |
| Traditional to protective ventilation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Traditional to protective ventilation
- description
- 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.
- interventionNames
- Procedure: Traditional to protective ventilation
- type
- OTHER
- label
- Protective to traditional ventilation
- description
- 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.
- interventionNames
- Procedure: Protective to traditional ventilation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.