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Clinical Trials/NCT02454582
NCT02454582CompletedPhase 4

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

Ass.-Prof. PD Dr. Klaus Ulrich Klein2 sites in 1 country40 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
The changes of rSO2 under CPAP therapy

Study Overview

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.

Detailed Description

BACKGROUND

Near infrared spectroscopy (NIRS) is a non-invasive method for the measurement of blood flow in tissues, first used for cerebral tissue oxygenation in 1977. 1 NIRS is a spectroscopic technique, which uses electromagnetic waves (700-950nm), an emitter and a detector. In the last 20 years there was an enormous development in the instrumentation and application of NIRS. This technique now allows for measuring the oxygenation of the brain tissue. 2-13 The INVOS Brain Oxymeter (IBO) is a reliable trend monitor for changes in regional cerebral oxygenation (rSO2) and correlates with the hemoglobin saturation in venous, capillary and arterial blood, using an algorithm based upon the Beer-Lambert law. 4,14 The IBO system uses light, with wavelengths between 730-810 nm, that penetrates layers of the human body, among them the skin, the scull and the brain. It is either scattered within the tissue or absorbed by present chromophores. In the rather transparent near infrared region, there are many absorbing light chromophores, but only three are important as far as the oxygenation is concerned, namely hemoglobin (HbO2), deoxyhemoglobin (Hb) and cytochrome oxidase (CtOx). Oxygenated and deoxygenated hemoglobin absorb light at different wavelengths, allowing a differentiation of these two forms of hemoglobin.15 The sensors, ("SomaSensors"), are applied to the patient's forehead with an integrated medical-grade adhesive.16 The method is applied by using two source-detector distances in the sensor: a "near" one (shallow), 3 cm from the source and a "far" one (deep), 4 cm from the source. Both samples penetrate the tissue beneath the light source equally well, with the difference that the 4cm source-detector measures signals deeper in the brain.8,17 The subtraction of the near sample from the far one should leave a signal originating predominantly from the brain cortex. 16 The proper management of brain oxygenation is an essential component of all anaesthesiologic procedures. Nevertheless, the brain remains one of the least monitored organs during the perioperative phase and intensive care therapy. Up until now, the anaesthesiological application of NIRS as a method for measuring the cerebral oxygenation has only been investigated in patients undergoing cardiac surgery or cerebrovascular surgery, elderly patients undergoing major abdominal surgery and neonatal infants. 18-21 These studies indicate that the measured cerebral oxygenation is affected by the relative proportion of blood in the arterial or venous part of the capillary bed, the hemoglobin concentration and the systemic saturation in addition to the cardiac output. The precise consequences of alterations in the systemic saturation (SaO2) on the cerebral oxygenation (rSO2) remain unknown. It is a current assumption that rSO2 is directly associated with Sa02, so that an increase of SaO2 also leads to an increase of rSO2. The amount of oxygen in the arterial blood depends on the inspired oxygen and the pulmonary gas exchange. These two parameters are primarily affected by the individual's respiratory ventilation. Patients with chronic respiratory failure, or just a temporary (acute) breathing deficiency (e.g. after general anesthesia), are routinely treated with continuous positive airway pressure (CPAP) therapy. It is also commonly used in the treatment of sleep apnea and in neonates (especially premature infants). In these patients CPAP ventilation may prevent the need of tracheal (re-) intubation, or enable earlier extubation.

CPAP therapy was developed by Dr. George Gregory and colleagues in the neonatal ICU at the University of California, San Francisco in 1971 22, and then modified by Professor Colin Sullivan at Royal Prince Alfred Hospital in Sydney, Australia, in 1981. 23 Initially the CPAP therapy was mainly used for the treatment of obstructive sleep apnea at home. Nowadays it is commonly applied in ICUs as a form of non-invasive mechanical ventilation. There it is usually reserved for subgroups of patients where the oxygen treatment via a facemask is insufficient. Patients on CPAP therapy are closely monitored in the ICU setting. The treatment supports the patient's spontaneous breathing by building up a positive end expiratory pressure (PEEP). The pressure required by most patients ranges between 5 and 12 cmH2O. The patient can individually determine his or her own respiratory frequency as well as the depth of respiration.

Objectives:

The primary study goal is the investigation of the effect of CPAP therapy on rSO2 in relation to the vital parameters, hemoglobin, SaO2 (analyzed by BGA) and SpO2. These combined measurements can be used to further describe the effect of CPAP therapy on rSO2. So far, this kind of study has not been performed on patients in the ICU. Therefore, this project aims at gaining new insights into the influence of CPAP therapy on the cerebral saturation. Additionally, differences in SaO2 and vital parameters will be correlated to the rSO2. Also the occurrence of vomiting and nausea, headache and agitation during the CPAP therapy will be registered.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

The changes of rSO2 under CPAP therapy

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

Secondary Outcomes

  • 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))

Investigators

Sponsor
Ass.-Prof. PD Dr. Klaus Ulrich Klein
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ass.-Prof. PD Dr. Klaus Ulrich Klein

Ass.-Prof. PD Dr. Klaus Ulrich Klein

Medical University of Vienna

Study Sites (2)

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