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Transmitted Lung Pressures With Biphasic Chest Cuirass

Primary Purpose

Lung Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biphasic Chest Cuirass
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Diseases focused on measuring Pediatrics, biphasic chest cuirass, transpulmonary pressure

Eligibility Criteria

6 Months - 5 Years (Child)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Oishei Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biphasic Chest Cuirass Arm

Arm Description

This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass.

Outcomes

Primary Outcome Measures

Transpulmonary Pressure Deliverance
Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2019
Last Updated
March 3, 2022
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03799588
Brief Title
Transmitted Lung Pressures With Biphasic Chest Cuirass
Official Title
Transmitted Lung Pressure Values With Biphasic Chest Cuirass
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
personnel have left the facility
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Pediatrics, biphasic chest cuirass, transpulmonary pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biphasic Chest Cuirass Arm
Arm Type
Experimental
Arm Description
This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass.
Intervention Type
Device
Intervention Name(s)
Biphasic Chest Cuirass
Intervention Description
Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.
Primary Outcome Measure Information:
Title
Transpulmonary Pressure Deliverance
Description
Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are between the age of 6 months and 5 years Undergo circumcision, hypospadias repair, or orchidopexy in the operating room of the John R. Oishei Children's Hospital Exclusion Criteria: Previous history of chronic lung disease or cyanotic heart disease or Patients with significant chest wall abnormalities or other abnormalities that preclude proper placement of the biphasic chest cuirass.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bree C Kramer, DO
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oishei Children's Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9142069
Citation
Scholz SE, Knothe C, Thiel A, Hempelmann G. Improved oxygen delivery by positive pressure ventilation with continuous negative external chest pressure. Lancet. 1997 May 3;349(9061):1295-6. doi: 10.1016/S0140-6736(05)62507-X. No abstract available.
Results Reference
background
PubMed Identifier
7653758
Citation
Petros AJ, Fernando SS, Shenoy VS, al-Saady NM. The Hayek oscillator. Nomograms for tidal volume and minute ventilation using external high frequency oscillation. Anaesthesia. 1995 Jul;50(7):601-6. doi: 10.1111/j.1365-2044.1995.tb15112.x.
Results Reference
background

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Transmitted Lung Pressures With Biphasic Chest Cuirass

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