Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery

NCT ID: NCT06771232

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-30

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.

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.

Conditions

Intracranial Pressure Increase; Mechanical Ventilation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Subdural pressure measurement

Subdural intracranial pressure (SDIP) will observed during an alveolar recruitment maneuver and best PEEP titatration. SDIP will be measured while mechanical ventilation is maintained using the identified best PEEP.

Intervention Type: PROCEDURE

Other Intervention Names

Alveolar recruitment maneuver and decremental PEEP titration

Eligibility Criteria

Inclusion Criteria

• ASA classification I-III.
• Elective cranial neurosurgery.

Exclusion Criteria

• ASA classification IV or higher.
• Documented intracranial hypertension.
• Severe pulmonary disease (e.g., asthma, COPD).
• Emergency surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felipe Maldonado, M.D., M.Sc.

Role: STUDY_CHAIR

Hospital Clinico de la Universidad de Chile

Locations

Hospital Clínico de la Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Central Contacts

Felipe Maldonado, M.D., M.Sc.

Role: CONTACT

fmaldonado@uchile.cl

+56 2 2978 8221

Roberto González, M.D.

Role: CONTACT

rgonzalezcor@gmail.com

+56 2 2978 8221

Facility Contacts

Felipe Maldonado

Role: primary

Roberto González

Role: backup

Other Identifiers

OAIC 1463/24

Identifier Type: -

Identifier Source: org_study_id