Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery

NCT06771232 | Not Yet Recruiting

• 1 other identifier: OAIC 1463/24
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Pressure Increase; Mechanical Ventilation Complication

Keywords

Positive end expiratory pressure; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• Subdural intracranial pressure (sICP) mmHg

  Change in sICP during an alveolar recruitment maneuver (ARM)

  during the procedure

Secondary Outcomes (1)

• Pulmonary mechanics parameters

  Intraoperative

Interventions

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.

Also known as: Alveolar recruitment maneuver and decremental PEEP titration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intracranial disease undergoing elective intracranial surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico de la Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Felipe Maldonado, M.D., M.Sc.

  Hospital Clinico de la Universidad de Chile

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+56 2 2978 8221; fmaldonado@uchile.cl

Roberto González, M.D.

CONTACT

+56 2 2978 8221; rgonzalezcor@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 13, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)