Impact of Biphasic Cuirass Ventilation Compared to Non Invasive Ventilation in High Risk Extubations

Not Applicable

Not yet recruiting

• Conditions: Respiratory Failure; Extubation Failure

• Registration Number: NCT07067502
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

subjects on mechanical ventilator who are about to be extubated to Non invasive ventilation because the physician thinks they are high risk for failure will be approached and consented for our study. Once randomized they will either be on the standard of care Non invasive arm or the intervention arm which would mean they are placed on the Biphasic cuirass ventilation.

Detailed Description

We are planning on conducting a pilot study to assess if Biphasic cuirass ventilator is non inferior to Non invasive ventilation in high risk patients who are usually extubated to Non Invasive ventilation per current standard of care.

We will identify daily in our Medical Intensive care unit patients who have passed their spontaneous breathing trials and are being planned on being extubated to Non invasive ventilation per their treating Physician and will screen them for suitability and if so then one of our study team will approach patient and or their durable power of attorney and explain about our study and possible risks vs benefit and if they are agreeable will get a written consent and then they are randomized to either the Non invasive arm (per current standard of care) vs Biphasic cuirass ventilation arm (intervention arm).

We plan on assessing them per current standard of care with blood gas and other routine standard laboratory and or imaging. The subjects will not be compensated and they will be made aware of this upfront. Also their participation is completely voluntary and they will not get any additonal charge for taking part in the study. Assuming they tolerate the biphasic cuirass ventilator we anticipate them being on it anywere from 1-4 days.

Study Timeline

• Study First Submitted: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Start: 2025-07-25
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• High risk extubation patients in the Medical Intensive care units who are being thought to be placed on non invasive ventilator post extubation.

Exclusion Criteria

• Age <18 or >80
• Pregnant
• Inmate/Prisoner
• Chest wall defects
• BMI >50
• History of Diaphragmatic paralysis
• History of Neuromuscular disease
• Contraindication to study device (open chest wound, flail chest, complex thoracic surgeries in the past)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations.	1 year	Primary outcome will try to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations - In other words we are comparing and calculating the rate of re-intubations in these patients in the two arms viz. Standard of care Non Invasive Positive Pressure ventilation vs intervention arm using the Biphasic Cuirass Ventilation.