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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
Sponsor:
Information provided by (Responsible Party):
Bree Cyrene Kramer, State University of New York at Buffalo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Diseases Device: Biphasic Chest Cuirass Not Applicable

Detailed Description:

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)
Primary Purpose: Other
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Are between the age of 6 months and 5 years
  2. Undergo circumcision, hypospadias repair, or orchidopexy in the operating room of the John R. Oishei Children's Hospital

Exclusion Criteria:

  1. Previous history of chronic lung disease or cyanotic heart disease or
  2. Patients with significant chest wall abnormalities or other abnormalities that preclude proper placement of the biphasic chest cuirass.

Information from the National Library of Medicine

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


Contacts
Contact: Bree C Kramer, DO 716-323-0239 bkramer@upa.chob.edu
Contact: Christopher Heard, MBChB 716-323-0201 cheard@upa.chob.edu

Locations
United States, New York
Oishei Children's Hospital Recruiting
Buffalo, New York, United States, 14203
Contact: Bree C Kramer, DO    716-323-0239    bkramer@upa.chob.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Bree C Kramer, DO University at Buffalo

Publications:
Responsible Party: Bree Cyrene Kramer, Assistant Clinical Professor of Pediatrics, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03799588     History of Changes
Other Study ID Numbers: STUDY00002374
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bree Cyrene Kramer, State University of New York at Buffalo:
Pediatrics
biphasic chest cuirass
transpulmonary pressure

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases