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

NCT07067502 | Not Yet Recruiting

• 1 other identifier: 455329
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure; Extubation Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Non Invasive ventilator arm (per current standard of care)

ACTIVE COMPARATOR

per current standard of care

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

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

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

Interventions

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.

Biphasic cuirass ventilator arm; Non Invasive ventilator arm (per current standard of care)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Hayek Medical: collaborator

Related Publications (5)

• 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.

  PMID: 24323843 RESULT

• 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.

  PMID: 16737982 RESULT

• 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.

  PMID: 16224108 RESULT

• 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.

  PMID: 16276167 RESULT

• 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.

  PMID: 28860265 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Dennis B Chairman, MD

  T

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis B Chairman, MD

CONTACT

573 884 1057; chairmand@umsystem.edu

Tamar Gubeladze, MD

CONTACT

573 884 0808; gubeladzet@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share