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

ConditionsRespiratory Failure Extubation Failure

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-80

SponsorUniversity of Missouri-Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 or >80

Pregnant

Inmate/Prisoner

Chest wall defects

Trial design

Design model

Parallel

Treatments tested in this trial

Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm
Device
As opposed to patients being placed on Non invasive ventilation (CPAP or BiPAP) the intervention arm patients will be placed on the Biphasic cuirass ventilator which is a form of negative pressure ventilator.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Non Invasive ventilator arm (per current standard of care)Active comparator 1 intervention

Group B: Biphasic cuirass ventilator armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations.

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.

Time frame

1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri-Columbia

Lead sponsor

Hayek Medical

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: