Respiratory FailureNCT07067502
Impact of Biphasic Cuirass Ventilation Compared to Non Invasive Ventilation in High Risk Extubations
A study testing Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm in people with Respiratory Failure and Extubation Failure, run by University of Missouri-Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Respiratory Failure, Extubation Failure
- What is being tested?
- Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk extubation patients in the Medical Intensive care units who are being thought to be placed on non invasive ventilator post extubation.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Biphasic Cuirass Ventilation Compared to Non-Invasive Ventilation in High Risk Extubations
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.
Read the 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
- Being tested
- Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention armDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non Invasive ventilator arm (per current standard of care) | Active comparator | per current standard of care Receives: 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. Receives: Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Hayek Medical
- Responsible party
- Principal investigator, Dennis Chairman, University of Missouri-Columbia
- Investigators
- Dennis B Chairman, MD, Principal investigator, T
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067502
- Sponsor's protocol ID
- 455329
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't need individual personalized data as most data will be grouped in either arms and would include age sex BMI and disease condition and their personalized data are not necessary for the research paper.
Publications
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.
PubMed 24323843El-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.
PubMed 16737982Ferrer 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.
PubMed 16224108Nava 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.
PubMed 16276167Rochwerg 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.
PubMed 28860265
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biphasic Cuirass Ventilation Compared to Non-Invasive Ventilation in High Risk Extubations
- ClinicalTrials.gov ID
- NCT07067502
- Acronym / sponsor ID
- 455329
- Conditions
- Respiratory Failure, Extubation Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Hayek Medical
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Invasive ventilator arm (per current standard of care) | Active comparator | Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention armper current standard of care |
| Biphasic cuirass ventilator arm | Experimental | Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention armpatients in this arm will be the intervention arm and will be placed on the Biphasic cuirass ventilator. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- High risk extubation patients in the Medical Intensive care units who are being thought to be placed on non invasive ventilator post extubation.
Key exclusion criteria (8 listed)
- Age <18 or >80
- Pregnant
- Inmate/Prisoner
- Chest wall defects
- BMI >50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention armAs 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. | Device | Biphasic cuirass ventilator arm, Non Invasive ventilator arm (per current standard of care) |
Primary outcome
to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Results publication: PubMed 24323843Burns 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.
- Results publication: PubMed 16737982El-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.
- Results publication: PubMed 16224108Ferrer 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.
- Results publication: PubMed 16276167Nava 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.
- Results publication: PubMed 28860265Rochwerg 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.
- Individual participant dataSharing planned: No. we don't need individual personalized data as most data will be grouped in either arms and would include age sex BMI and disease condition and their personalized data are not necessary for the research paper.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis B Chairman, MD principal investigator
T
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm in people with Respiratory Failure and Extubation Failure, run by University of Missouri-Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis B Chairman, MD (573 884 1057, chairmand@umsystem.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07067502, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.