Transmitted Lung Pressures With Biphasic Chest Cuirass
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|ClinicalTrials.gov Identifier: NCT03799588|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases||Device: Biphasic Chest Cuirass||Not Applicable|
Conventional mechanical ventilation is known as positive pressure ventilation (PPV) because the machine delivers positive pressure directly into the airways to ventilate and expand the lungs. In a healthy lung, inflation occurs when the pressure inside the lung is greater than the pressure outside the lung. This transpulmonary pressure is the difference between the pressure inside the lung (in the alveolus) and the pressure just outside the lung (the pleural cavity). Since positive pressure ventilation delivers pressure directly into the airways, the transpulmonary pressure is increased by making the lung pressure more positive. This is markedly different than physiologic breathing and carries an increased risk of ventilator-associated lung injury1. In the setting of sick lungs, where the pressure required to open collapsed areas of lung may be more than areas of healthy lung, this higher pressure can in turn cause damage to the areas of healthy lung. The known effects of this ventilator-associated lung injury from positive pressure ventilation can be avoided with the use of negative pressure ventilation. In negative pressure ventilation (NPV), the transpulmonary pressure is increased by making the pleural pressure more negative. This is achieved by using a plastic shell that covers the chest and generates negative pressure between the plastic shell and the chest. This pressure is distributed more evenly across a large surface of the chest wall and results in more uniform lung expansion. As a result, NPV results in better oxygen delivery and less lung injury than positive pressure ventilation2.
However, despite the extensive use of NPV in other countries, there is little data available regarding the transpulmonary pressure that these machines can generate; i.e. how well does negative pressure in the plastic shell transmit to the pleural cavity to expand the lung. There is a large amount of data supporting the use of biphasic cuirass ventilation to minimize lung damage3 and improve hemodynamics4-9, but no studies have been done to date that look at the transpulmonary pressure and how it differs depending on age and size. It is still unclear what optimal pressure is required via the chest cuirass to expand and ventilate the lungs via. It is also unknown what maximum pressures can be used before the lung becomes overinflated and complications arise.
This study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||After routine intubation for elective urologic procedures in the OR, the patient will be placed on a biphasic chest cuirass after anesthesia induction. A esophageal manometer will then be placed to measure transpulmonary pressures. The patient will be switched off the anesthesia ventilator and the biphasic chest cuirass will begin negative pressure ventilation. During this time, the patient will continue to receive inhalation anesthetic gas. After 30 minutes, the biphasic chest cuirass will terminate and the patient will again receive positive pressure ventilation via the anesthesia ventilator.|
|Masking:||None (Open Label)|
|Official Title:||Transmitted Lung Pressure Values With Biphasic Chest Cuirass|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Biphasic Chest Cuirass Arm
This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass.
Device: Biphasic Chest Cuirass
Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.
- Transpulmonary Pressure Deliverance [ Time Frame: 1 year ]Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799588
|Contact: Bree C Kramer, DOemail@example.com|
|Contact: Christopher Heard, MBChBfirstname.lastname@example.org|
|United States, New York|
|Oishei Children's Hospital||Recruiting|
|Buffalo, New York, United States, 14203|
|Contact: Bree C Kramer, DO 716-323-0239 email@example.com|
|Principal Investigator:||Bree C Kramer, DO||University at Buffalo|