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

NCT02454582 | Completed Phase 4

• 1 other identifier: EK Number: 1264/2014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• The changes of rSO2 under CPAP therapy

  2x15min: with and without CPAP in one session (in total about 30 minutes)

Secondary Outcomes (2)

• rSO2 trend with and without NIV

  2x15min: with and without CPAP in one session (in total about 30 minutes)

• Correlation of rSO2 to other parameters (SpO2, Bloodpressure)

  2x15min: with and without CPAP in one session (in total about 30 minutes)

Study Arms (2)

Group 1

OTHER

15min without CPAP, then 15min with CPAP NIRS measurement, Somanetics INVOS Cerebral Oxymeter 5100C

Device: Somanetics INVOS Cerebral Oxymeter 5100C

Group 2

OTHER

15min with CPAP, then 15min without CPAP NIRS measurement, Somanetics INVOS Cerebral Oxymeter 5100C

Device: Somanetics INVOS Cerebral Oxymeter 5100C

Interventions

Somanetics INVOS Cerebral Oxymeter 5100C DEVICE

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Medical University of Vienna, Anesthesia

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Klaus Markstaller, Prof.Dr

  MUW, Department of Anaesthesia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass.-Prof. PD Dr. Klaus Ulrich Klein

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

AU (1)