Nervous System Neoplasms Clinical Trial
Official title:
Protective Ventilation in Neurosurgery, a Pilot 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.
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.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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