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

University of Missouri (MU)

Status: Not yet enrolling

Conditions: Respiratory Failure; Extubation Failure

Treatments: Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm

Study type: Interventional

Funder types: Other

Identifiers

NCT07067502

455329

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Non Invasive ventilator arm (per current standard of care)

Active Comparator group

Description:

per current standard of care

Treatment:

Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm

Biphasic cuirass ventilator arm

Experimental group

Description:

patients in this arm will be the intervention arm and will be placed on the Biphasic cuirass ventilator.

Treatment:

Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm