Ventilatory FailureNCT04258020
Postextubation Management in Patients at Risk for Extubation Failure
A study testing BiPAP and HFNC in people with Ventilatory Failure, run by OhioHealth at 1 site in United States.
Trial summary
At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Failure
- What is being tested?
- BiPAP and HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 2 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented high-risk factors of interest [congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance]
- The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L)
- Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation
- Only primary extubations will be included
Who cannot join
- Undergoing terminal extubation or placed on comfort care
- Home ventilator use
- Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)
Trial locations and contacts
1 site in 1 country.
United States1 site
OhioHealth Grant Medical Center
Columbus, Ohio, 43215
About this study
Official title: Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.
Read the detailed description
It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging.
Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients.
The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.
- Conditions
- Ventilatory Failure
- Being tested
- BiPAP, HFNC
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAPDevice
Bilevel Positive Airway Pressure (BiPAP) oxygen administration
HFNCDevice
Heated High Flow Nasal Cannula oxygen administration
| Study group | Role | What they receive |
|---|---|---|
| Experimental: alternating BiPAP and HFNC | Experimental | Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation Receives: Device: BiPAP; Device: HFNC |
| Historical Control: standard of care | No intervention | A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intubation Within 72 Hours
The number of patients who require re-intubation
Measured: 72 hours following extubation
Secondary outcomes (6)
Re-intubation Within 1 Week
The number of patients who require re-intubation
Measured: 1 week following extubation
Length of Stay
Hospital length of stay
Measured: Through hospital discharge, an average of 10.9 ± 1.91 days
Ventilator Time
The total duration of time patients spend on a ventilator
Measured: Through hospital discharge, an average of 10.9 ± 1.91 days
Mortality
The proportion of patients who expire during the hospital stay
Measured: Through hospital discharge, an average of 10.9 ± 1.91 days
Adverse Event Rate
The proportion of patients experiencing an adverse event
Measured: Through 1 week following extubation
30-day Readmission
The proportion of patients who require re-admission within 30 days of discharge
Measured: 30 days following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 Feb 2020
- Primary completion25 Feb 2020
- Study completion2 Apr 2020
Why it stopped: Significant impact of COVID pandemic on ability to conduct study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventilatory 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiran Devulapally, MD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258020
- Sponsor's protocol ID
- 1332767
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2020
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
- ClinicalTrials.gov ID
- NCT04258020
- Acronym / sponsor ID
- 1332767
- Conditions
- Ventilatory Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant impact of COVID pandemic on ability to conduct study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.
Detailed description
It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging.
Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients.
The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: alternating BiPAP and HFNC | Experimental | Device: BiPAP, Device: HFNCPatients will be placed on alternating BiPAP and HFNC for 24 hours following extubation |
| Historical Control: standard of care | No intervention | –A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented high-risk factors of interest [congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance]
- The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L)
- Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation
- Only primary extubations will be included
Key exclusion criteria (3 listed)
- Undergoing terminal extubation or placed on comfort care
- Home ventilator use
- Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)
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 |
|---|---|---|
| BiPAPBilevel Positive Airway Pressure (BiPAP) oxygen administration | Device | Experimental: alternating BiPAP and HFNC |
| HFNCHeated High Flow Nasal Cannula oxygen administration | Device | Experimental: alternating BiPAP and HFNC |
Primary outcome
Re-intubation Within 72 Hours
Time frame: 72 hours following extubation
The number of patients who require re-intubation
6 secondary outcomes
Re-intubation Within 1 Week
Time frame: 1 week following extubation
Length of Stay
Time frame: Through hospital discharge, an average of 10.9 ± 1.91 days
Ventilator Time
Time frame: Through hospital discharge, an average of 10.9 ± 1.91 days
Mortality
Time frame: Through hospital discharge, an average of 10.9 ± 1.91 days
Adverse Event Rate
Time frame: Through 1 week following extubation
30-day Readmission
Time frame: 30 days following discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Kiran Devulapally, MD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP and HFNC in people with Ventilatory Failure, run by OhioHealth at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intubation Within 72 Hours (time frame: 72 hours following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2022.