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Effect of Non-invasive Ventilation (NIV) on Cerebral Oxygenation

NCT02454582 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-24

No results posted yet for this study

Summary

SUMMARY AND AIM

Background:

The proper management of brain oxygenation is an essential component of all anaesthesiologic procedures. Nevertheless, the brain remains one of the least monitored organs in the perioperative phase and intensive care therapy.

The INVOS Brain Oxymeter (IBO) is a reliable trend monitor for changes in regional cerebral oxygenation (rSO2).

It is a current assumption that rSO2 directly correlates with Sa02, which can be influenced by different ventilation assistance systems, e.g. CPAP therapy.

Objectives:

The project aims at investigating changes of rSO2 in patients undergoing CPAP therapy for max. 15 minutes, in order to evaluate the effect of CPAP on cerebral oxygenation.

Methods:

NIRS measurement (with IBO) will be performed on the temporoparietal cortex on both sides of the head. The trial will consist of two parts i.e. with or without ventilatory assistance. The order of starting the study with or without CPAP therapy will be randomized. During each part the measurements will be performed until reaching a steady state (no change in rSO2 ± 2% for 3 min) but with a maximum duration of 15min. After each interval a BGA (blood gas analysis) will be performed.

Conditions

  • Respiratory Insufficiency

Interventions

DEVICE

Somanetics INVOS Cerebral Oxymeter 5100C

Non- invasive transcranial near infrared cerebral oxygenation with or without CPAP

Sponsors & Collaborators

  • Ass.-Prof. PD Dr. Klaus Ulrich Klein

    lead OTHER

Principal Investigators

  • Klaus Markstaller, Prof.Dr · MUW, Department of Anaesthesia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Austria

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 NCT02454582 on ClinicalTrials.gov