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Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation

NCT05961917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-13

No results posted yet for this study

Summary

The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses.

The main question it aims to answer is that how high PEEP level effects the regional cerebral oxygen saturation in patients with high intracranial pressure due to mass effect. Patients will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O). Researchers will compare the changes of regional cerebral oxygen saturations between two groups by near infra-red spectroscopy.

Conditions

  • Regional Cerebral Oxygen Saturation

Interventions

OTHER

5 cmH2O Positive end-expiratory pressure (PEEP)

PEEP will be set at 5 cmH2O

OTHER

10 cmH2O Positive end-expiratory pressure (PEEP)

PEEP will be set at 10 cmH2O

Sponsors & Collaborators

  • Bozyaka Training and Research Hospital

    lead OTHER

Principal Investigators

  • Halide H Şahinkaya, MD · University of Health Sciences İzmir Bozyaka Education and Research Hospital

  • Çağlar Ayar, MD · University of Health Sciences İzmir Bozyaka Education and Research Hospital

  • Alper Tabanlı, MD · University of Health Sciences İzmir Bozyaka Education and Research Hospital

  • Zeki T Tekgül, MD · University of Health Sciences İzmir Bozyaka Education and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2023-10-15
Completion
2023-11-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961917 on ClinicalTrials.gov