The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation

The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation

Sponsors

Lead sponsor: Hasselt University

Collaborator: Ziekenhuis Oost-Limburg

Source Hasselt University
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.

Overall Status Unknown status
Start Date May 2015
Completion Date May 2018
Primary Completion Date May 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The association between HFPV and cerebral oxygen saturation Two hours before switch to HFPV until 24 hours after the switch to HFPV
Enrollment 50
Condition
Intervention

Intervention type: Device

Intervention name: Near-Infrared Spectroscopy (NIRS)

Description: Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation

Arm group label: study group

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Frank Jans, prof. dr. Principal Investigator Ziekenhuis Oost-Limburg, Hasselt University
Overall Contact

Last name: Ward Eertmans, drs.

Email: [email protected]

Location
facility status contact investigator
Ziekenhuis Oost-Limburg Recruiting Ward Eertmans, drs. [email protected] Frank Jans, prof. dr. Principal Investigator Ward Eertmans, drs Sub-Investigator Cathy De Deyne, prof. dr. Sub-Investigator Pascal Vanelderen, prof. dr. Sub-Investigator Willem Boer, dr. Sub-Investigator Ward Eertmans, drs. Sub-Investigator
Location Countries

Belgium

Verification Date

March 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Hasselt University

Investigator full name: prof. dr. Frank Jans

Investigator title: prof. dr.

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: study group

Arm group type: Other

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

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov