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NCT Number: NCT06771232

Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico de la Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location contact

Felipe Maldonado

CONTACT

Roberto González

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subdural pressure measurement

Procedure

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.

Other names: Alveolar recruitment maneuver and decremental PEEP titration

Primary outcomes

  1. Subdural intracranial pressure (sICP) mmHg

    Time frame: during the procedure

    Change in sICP during an alveolar recruitment maneuver (ARM)

Secondary outcomes

  1. Pulmonary mechanics parameters

    Time frame: Intraoperative

    To describe pulmonary mechanics parameters, including plateau pressure (cmH2O) and driving pressure.(cmH2O)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+56 2 2978 8221

Roberto González, M.D.

CONTACT

[email protected]

+56 2 2978 8221

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Impact of Lung Recruitment Maneuvers and Positive End-Expiratory Pressure (PEEP) on Intracranial Pressure in Patients Undergoing Cranial Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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