Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery

January 9, 2025 updated by: University of Chile

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
      • Santiago, Chile, 8380456
        • Hospital Clinico de la Universidad de Chile
        • Contact:
          • Felipe Maldonado
        • Contact:
          • Roberto González

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with intracranial disease undergoing elective intracranial surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subdural intracranial pressure (sICP) mmHg
Time Frame: during the procedure
Change in sICP during an alveolar recruitment maneuver (ARM)
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary mechanics parameters
Time Frame: Intraoperative
To describe pulmonary mechanics parameters, including plateau pressure (cmH2O) and driving pressure.(cmH2O)
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

  • Study Chair: Felipe Maldonado, M.D., M.Sc., Hospital Clinico de la Universidad de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAIC 1463/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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