Transmitted Lung Pressures With Biphasic Chest Cuirass

NCT03799588 | Withdrawn

• 1 other identifier: STUDY00002374
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

Pediatrics; biphasic chest cuirass; transpulmonary pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Biphasic Chest Cuirass Arm

EXPERIMENTAL

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

Interventions

Biphasic Chest Cuirass DEVICE

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

Biphasic Chest Cuirass Arm

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

Related Publications (2)

• 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.

  PMID: 9142069 BACKGROUND

• 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.

  PMID: 7653758 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Bree C Kramer, DO

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: January 8, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)