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

NCT ID: NCT07067502

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2026-07-30

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.

Conditions

Respiratory Failure; Extubation Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non Invasive ventilator arm (per current standard of care)

per current standard of care

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Biphasic cuirass ventilator arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hayek Medical

UNKNOWN

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Dennis Chairman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis B Chairman, MD

Role: PRINCIPAL_INVESTIGATOR

T

Central Contacts

Dennis B Chairman, MD

Role: CONTACT

chairmand@umsystem.edu

573 884 1057

Tamar Gubeladze, MD

Role: CONTACT

gubeladzet@health.missouri.edu

573 884 0808

References

Burns KE, Meade MO, Premji A, Adhikari NK. Noninvasive positive-pressure ventilation as a weaning strategy for intubated adults with respiratory failure. Cochrane Database Syst Rev. 2013 Dec 9;2013(12):CD004127. doi: 10.1002/14651858.CD004127.pub3.

Reference Type: BACKGROUND

PMID: 24323843 (View on PubMed)

El-Solh AA, Aquilina A, Pineda L, Dhanvantri V, Grant B, Bouquin P. Noninvasive ventilation for prevention of post-extubation respiratory failure in obese patients. Eur Respir J. 2006 Sep;28(3):588-95. doi: 10.1183/09031936.06.00150705. Epub 2006 May 31.

Reference Type: BACKGROUND

PMID: 16737982 (View on PubMed)

Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.

Reference Type: BACKGROUND

PMID: 16224108 (View on PubMed)

Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. doi: 10.1097/01.ccm.0000186416.44752.72.

Reference Type: BACKGROUND

PMID: 16276167 (View on PubMed)

Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

Reference Type: BACKGROUND

PMID: 28860265 (View on PubMed)

Other Identifiers

455329

Identifier Type: -

Identifier Source: org_study_id