Effects of Non-invasive Ventilation (NIV) on Cerebral Oxygenation.

NCT04038398 | Unknown DMC

• 1 other identifier: EK Nr: 1614/2019
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proper management of brain oxygenation is an essential component of all anesthesiologic procedures. Nevertheless, the brain remains one of the least monitored organs in the perioperative phase and intensive care therapy. In the current study the effects of continuous positive airway pressure (CPAP) with different ventilation parameters (FiO2 21% - 50% - 100%) on cerebral and peripheral oxygenation (rSO2) will be examined. The INVOS Brain oximeter (IBO) is a reliable trend monitor for changes in regional cerebral oxygenation (rSO2). Therefore rSO2 will be measured on the forehead and the arm. In a randomised way the rSO2 will be monitored for 30 minutes (3x10min) with different FiO2 settings. The randomisation refers to the order of the applied FiO2, each patient is therefore its own control. Additionally vital parameters (heart rate, blood pressure, SpO2) will be recorded and blood gas analysis will be performed.

Conditions

Cerebral Oxygenation

Outcome Measures

Primary Outcomes (1)

• rSO2 (cerebral)

  The primary endpoint of this study is the change of cerebral rSO2 (%) under CPAP therapy.

  30 minutes

Secondary Outcomes (7)

• rSO2 (peripheral)

  30 minutes

• Association of rSO2 with blood gas analysis (pO2)

  30 minutes

• Association of rSO2 with blood gas analysis (pCO2)

  30 minutes

• Association of rSO2 with blood gas analysis SO2

  30 minutes

• Association of rSO2 with peripheral oxygen saturation SpO2

  30 minutes

Study Arms (2)

FiO2 : 100% - 50% - 21%

OTHER

see above

Procedure: Non-invasive ventilation with different FiO2 settings

FiO2: 21% - 50% - 100%

OTHER

see above

Procedure: Non-invasive ventilation with different FiO2 settings

Interventions

Non-invasive ventilation with different FiO2 settings PROCEDURE

CPAP therapy applied with different order of FiO2 settings.

FiO2 : 100% - 50% - 21%; FiO2: 21% - 50% - 100%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged from 18 years onwards
• treatment on ICUs (13C1, 13C2, 13C3, 13B1, 13I1, 9D, E11 (neurosurgical ICU )) of the Medical University Vienna
• CPAP therapy in the patient's routine clinical treatment
• patients willing to participate

You may not qualify if:

• delirium
• patients not willing to participate
• present severe neurological disorders
• present severe cardiac valvular disease
• known allergies to the medical-grade adhesive

Sponsors & Collaborators

• Medical University of Vienna: lead

Related Publications (1)

• Doerr C, Kietaibl C, Doerr K, Hagmann M, Baumann L, Kimberger O, Ullrich R, Markstaller K, Klein KU. Impact of CPAP on Forehead Near-infrared Spectroscopy Measurements in Patients With Acute Respiratory Failure: Truth or Illusion. J Neurosurg Anesthesiol. 2019 Oct;31(4):406-412. doi: 10.1097/ANA.0000000000000529.

  PMID: 30015697 RESULT

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Klaus Markstaller, MD, PHD

  Medical University Vienna

  STUDY DIRECTOR

Central Study Contacts

Claudius Doerr, MD, PHD

CONTACT

043 1 4040041000; claudius.doerr@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share