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Clinical Trials/NCT02545803
NCT02545803
Unknown
Not Applicable

The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation

Hasselt University1 site in 1 country50 target enrollmentStarted: May 2015Last updated:

Overview

Phase
Not Applicable
Sponsor
Hasselt University
Enrollment
50
Locations
1
Primary Endpoint
The association between HFPV and cerebral oxygen saturation

Overview

Brief Summary

Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma and postoperative complications. In an attempt to preserve or increase the oxygenation, conventional mechanical ventilation is initiated in these patients. Unfortunately, patients frequently become refractory to standard ventilatory techniques and as such, gas exchange remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the other hand, is an advanced mode of ventilation which can be a salvage option in these patient cohorts as it has already been proven to improve gas exchange with success. The volumetric diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially available system to deliver HFPV. This ventilator mechanically ventilates the lung by administering small successive subtidal volumes or percussions at unconventional high frequencies to reach an optimal diffusive oxygenation.

Since it has been known that hypoxemia due to a reduced oxygenation results in secondary brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range has an ameliorative influence on hypoxic events and in turn leads to a better clinical outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation by means of a switch to HFPV automatically leads to an increment in the cerebral tissue oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will investigate whether this alternation of ventilation strategy is associated with a (beneficial) change of the cerebral tissue oxygenation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV.

Exclusion Criteria

  • Age \< 18 years
  • Patients with COPD (chronic obstructive pulmonary disease)
  • Patients with asthma

Outcomes

Primary Outcomes

The association between HFPV and cerebral oxygen saturation

Time Frame: Two hours before switch to HFPV until 24 hours after the switch to HFPV

The primary objective is to investigate whether a switch from conventional mechanical ventilation to High Frequency Percussive Ventilation is associated with a change of the SctO2. Therefore, a comparison of SctO2-values two hours before and four hours after the switch will be made.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hasselt University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

prof. dr. Frank Jans

prof. dr.

Hasselt University

Study Sites (1)

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