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

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ClinicalTrials.gov Identifier: NCT02454582
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Ass.-Prof. PD Dr. Klaus Ulrich Klein, Medical University of Vienna

Brief 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.


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Somanetics INVOS Cerebral Oxymeter 5100C Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Non-invasive Ventilation (NIV) on Cerebral Oxygenation
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Group 1
15min without CPAP, then 15min with CPAP NIRS measurement, Somanetics INVOS Cerebral Oxymeter 5100C
Device: Somanetics INVOS Cerebral Oxymeter 5100C
Non- invasive transcranial near infrared cerebral oxygenation with or without CPAP

Group 2
15min with CPAP, then 15min without CPAP NIRS measurement, Somanetics INVOS Cerebral Oxymeter 5100C
Device: Somanetics INVOS Cerebral Oxymeter 5100C
Non- invasive transcranial near infrared cerebral oxygenation with or without CPAP




Primary Outcome Measures :
  1. The changes of rSO2 under CPAP therapy [ Time Frame: 2x15min: with and without CPAP in one session (in total about 30 minutes) ]

Secondary Outcome Measures :
  1. rSO2 trend with and without NIV [ Time Frame: 2x15min: with and without CPAP in one session (in total about 30 minutes) ]
  2. Correlation of rSO2 to other parameters (SpO2, Bloodpressure) [ Time Frame: 2x15min: with and without CPAP in one session (in total about 30 minutes) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients undergoing CPAP in the routine clinical treatment
  • women/men on following ICUs: 13C1, 13C2, 13C3, 13B1, 13I1, 9D, E11 (neurosurgery intensive care unit)
  • age above 18
  • patients willing to participate

Exclusion Criteria:

  • pregnancy
  • present neurological disorders
  • present cardiac valvular disease
  • patients not willing to participate
  • patients with allergies to the measurement sensor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454582


Locations
Austria
Medical University of Vienna, Anesthesia
Vienna, Austria, 1090
Sponsors and Collaborators
Ass.-Prof. PD Dr. Klaus Ulrich Klein
Investigators
Study Director: Klaus Markstaller, Prof.Dr MUW, Department of Anaesthesia

Responsible Party: Ass.-Prof. PD Dr. Klaus Ulrich Klein, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02454582     History of Changes
Other Study ID Numbers: EK Number: 1264/2014
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases