Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT06771232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery
Sponsor:
University of Chile
Organization:
Study Overview
Official Title:
Impact of Lung Recruitment Maneuvers and Positive End-Expiratory Pressure (PEEP) on Intracranial Pressure in Patients Undergoing Cranial Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High positive end-expiratory pressure (PEEP) levels required to achieve clinical benefits may increase ICP and reduce cerebral perfusion pressure (CPP) in patients at risk of intracranial hypertension.
However, individualizing ventilation parameters is essential for each patient. Among protective ventilation strategies, PEEP is key to preventing alveolar collapse. The PEEP level that minimizes alveolar collapse while avoiding overdistension of the pulmonary parenchyma is known as the Best PEEP. This study aims to evaluate the application of Best PEEP in cranial neurosurgery.
However, individualizing ventilation parameters is essential for each patient. Among protective ventilation strategies, PEEP is key to preventing alveolar collapse. The PEEP level that minimizes alveolar collapse while avoiding overdistension of the pulmonary parenchyma is known as the Best PEEP. This study aims to evaluate the application of Best PEEP in cranial neurosurgery.
Detailed Description:
In general anesthesia for neurosurgery, mechanical ventilation is the standard approach. However, mechanical ventilation can induce pulmonary parenchymal injury through various mechanisms, including volutrauma, barotrauma, and atelectrauma. These correspond to lung damage caused by high tidal volumes, elevated airway pressures, repetitive alveolar collapse, and reopening. Protective ventilation strategies include limiting tidal volume (Vt), applying positive end-expiratory pressure (PEEP), and performing alveolar recruitment maneuvers (ARM).
Historically, both ARM and higher levels of PEEP have been avoided in neurocritical patients, including those undergoing neurosurgery, due to concerns about their potential impact on intracranial pressure (ICP) and cerebral perfusion pressure (CPP). As postoperative pulmonary complications can significantly alter the prognosis of surgical patients, increasing hospital stay and healthcare costs, and, in neurocritical patients, compromising cerebral oxygenation, protective ventilation strategies may play a critical role in patients undergoing neurosurgery. Their historical exclusion from studies lacks demonstrated physiological justification.
Here, the investigators aim to evaluate the impact of intrathoracic pressure on ICP in neurosurgical patients.
Historically, both ARM and higher levels of PEEP have been avoided in neurocritical patients, including those undergoing neurosurgery, due to concerns about their potential impact on intracranial pressure (ICP) and cerebral perfusion pressure (CPP). As postoperative pulmonary complications can significantly alter the prognosis of surgical patients, increasing hospital stay and healthcare costs, and, in neurocritical patients, compromising cerebral oxygenation, protective ventilation strategies may play a critical role in patients undergoing neurosurgery. Their historical exclusion from studies lacks demonstrated physiological justification.
Here, the investigators aim to evaluate the impact of intrathoracic pressure on ICP in neurosurgical patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: