Transmitted Lung Pressures With Biphasic Chest Cuirass

NCT ID: NCT03799588

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2022-01-31

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.

Conditions

Lung Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biphasic Chest Cuirass

Intervention Type: DEVICE

Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.

Interventions

Biphasic Chest Cuirass

Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Bree Cyrene Kramer

Assistant Clinical Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bree C Kramer, DO

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

Oishei Children's Hospital

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9142069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7653758 (View on PubMed)

Other Identifiers

STUDY00002374

Identifier Type: -

Identifier Source: org_study_id