Hypercapnic Respiratory FailureNCT06047405
NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
A study testing Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) in people with Hypercapnic Respiratory Failure, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS and BIPAP S/T and hypothesize that AVAPS will result in a decreased length of stay in the ICU or on telemetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure
- What is being tested?
- Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Provision of signed and dated informed consent form directly by the patient; consent can also be obtained via a legal patient representative/health care proxy/surrogate
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Diagnosed with hypercapnic respiratory failure on admission (ABG)
- Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit
- Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure
Who cannot join
- Patients who require ventilation at predetermined tidal volumes
- Patients who require rapid and frequent IPAP adjustments to maintain a consistent tidal volume
- Age less than 18 years of age
- Currently intubated
- Chronic tracheostomy
- Pregnancy
Show all 14Show fewer
- Hypotension
- Epistaxis (nosebleed)
- Untreated pertussis
- Acute sinusitis or Otitis media
- Patients at risk of aspirating gastric contents
- Patients with lack of spontaneous respiratory drive
- Patients with the inability to maintain a patent airway or adequately clear secretions
- Prisoners or other institutionalized individuals
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Sara Velichkovikj, 212-434-4087, svelichkovik@northwell.edu
Zein Kattih, MD
About this study
The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS and BIPAP S/T and hypothesize that AVAPS will result in a decreased length of stay in the ICU or on telemetry. Currently, noninvasive ventilation is the standard of care for hypercapnic respiratory failure. However, the most effective mode for patients with hypercapnic respiratory failure is unclear.
Read the detailed description
- Overall Study Design and Plan
This is a single center, randomized trial that will include a total of 100 adult subjects aged 18 or older with hypercapnic respiratory failure of all etiologies (i.e. "all comers"). The investigators will randomize patients in a single-blinded (patient blinded) fashion to BIPAP S/T or AVAPS during the duration of their hospitalization. The investigators will assess ABG at baseline, 1 hour after initial placement on BIPAP S/T or AVAPS, and between hours 24-48 of use. The investigators will record the pre-NIV pH and PaCO2, post-NIV pH and PaCO2, length of hospital stay in the medical ICU or telemetry unit, days on NIV, need for intubation (if occurred), transition to medical ICU care in patients who were initially admitted to telemetry, and in-hospital mortality. All collected laboratory data are already done as part of usual care for all patients placed on NIV when a patient is on the telemetry unit or medical ICU. The groups will undergo stratified randomization based on whether they are initially admitted to medical ICU or medical telemetry. Patients from medical ICU or telemetry units will be randomized to one of the following arms:
Arm 1: AVAPS mode Arm 2 2: BIPAP S/T mode
- Conditions
- Hypercapnic Respiratory Failure
- Being tested
- Average Volume-Assured Pressure Support (AVAPS), Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)
- Keywords
- AVAPS, BIPAP, Hypercapnic respiratory failure, Noninvasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Average Volume-Assured Pressure Support (AVAPS)Device
A setting on noninvasive ventilator that allows setting of maximum and minimum inspiratory pressure and sets a target tidal volume. The inspiratory pressure varies breath to breath to ensure pre-set tidal volume is delivered.
Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)Device
A setting on noninvasive ventilator that allows setting of inspiratory pressure, inspiratory time, expiratory pressure, and backup rate to deliver variable tidal volumes.
| Study group | Role | What they receive |
|---|---|---|
| Average Volume-Assured Pressure Support (AVAPS) | Active comparator | Average Volume-Assured Pressure Support (AVAPS) setting on the noninvasive ventilator. The exact AVAPS setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response. Receives: Device: Average Volume-Assured Pressure Support (AVAPS) |
| Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) | Active comparator | Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) setting on the noninvasive ventilator. The exact BIPAP S/T setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response. Receives: Device: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay of telemetry length of stay
In patients admitted to the medical ICU, the primary endpoint is ICU length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge. In patients admitted to medical telemetry unit, the outcome is telemetry length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge.
Measured: within one week of hospital discharge (5-7 days)
Secondary outcomes (12)
Difference in PaCO2 value with NIV
Change in paCO2 on ABG (paCO2 before and after NIV use, measured as a numerical value in mmHg)
Measured: within 24-48 hours after noninvasive ventilation
Time to normalization of pH
Time to normalization of pH (hours)
Measured: at the time of hospital discharge (an average of 5-7 days)
Normalization of pH
Return to normal range of pH as defined by the laboratory normal values (Binary measure)
Measured: at the time of hospital discharge (an average of 5-7 days)
Days on NIV
Days on noninvasive ventilation
Measured: within one week of hospital discharge (5-7 days)
Need for intubation
Need for intubation
Measured: within one week of hospital discharge (5-7 days)
Need for ICU stay
Need for ICU stay (if disposition changed from telemetry unit)
Measured: within one week of hospital discharge (5-7 days)
Subgroup analysis (logistic regression or p-value) comparing outcomes 1- ICU or telemetry length of stay based on the underlying cause of hypercapnic respiratory failure
We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for these outcome- for 1. ICU or telemetry length of stay. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.
Measured: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 2- difference in paCO2 reported as difference between groups (with p-value and/or standard deviation)
We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 2- difference in PaCO2. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.
Measured: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 4- time to normalization of pH reported as difference between groups (with p-value and/or standard deviation)
We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 4- time to normalization of pH. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.
Measured: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 5- days on NIV reported as difference between groups (with p-value and/or standard deviation)
We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 5- days on NIV. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.
Measured: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 6- need for intubation reported as difference between groups (with p-value and/or standard deviation)
We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 6- need for intubation. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.
Measured: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 7- need for ICU stay reported as difference between groups (with p-value and/or standard deviation)
We will perform subgroup analysis of each cause of hypercapnic respiratory failure (such as COPD, pulmonary edema, altered mental status, etc) for outcome 7- need for ICU stay. We will use either logistic regression model or p-value to determine the difference for each subgroup. The results will be reported as difference between groups with statistical significance.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 Oct 2023
- Primary completion28 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Model description
- Patients from medical ICU or telemetry units will be randomized to one of the following arms: Arm 1: AVAPS mode Arm 2: BIPAP S/T mode
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margarita Oks, MD, Principal investigator, Lenox Hill Hospital/Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047405
- Sponsor's protocol ID
- 22-0745
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only researchers on involved in conducting the study will have access to the information collected in the study. 9.3 Data Handling and Record Keeping 9.3.1 Data Collection and Management All information accessed from the medical record will be de-identified. All data will be stored on an encrypted secure server, REDCap. 9.3.2 Confidentiality and Privacy Privacy will be protected as data will be collected within the Northwell Redcap data portal. All data will be de-identified prior to entry into REDCap. All communication between subjects and researchers will be conducted in a private setting.
Publications
Briones-Claudett KH, Esquinas Rodriguez A, Briones-Claudett MH, Puga-Tejada M, Cabrera Banos MDP, Pazmino Duenas CR, Torres Herrera CI, Grunauer M. Use of noninvasive mechanical ventilation with pressure support guaranteed with average volume in de novo hypoxaemic respiratory failure. A pilot study. Anaesthesiol Intensive Ther. 2018;50(4):283-290. doi: 10.5603/AIT.a2018.0036. Epub 2018 Oct 14.
PubMed 30317536Patout M, Gagnadoux F, Rabec C, Trzepizur W, Georges M, Perrin C, Tamisier R, Pepin JL, Llontop C, Attali V, Goutorbe F, Pontier-Marchandise S, Cervantes P, Bironneau V, Portmann A, Delrieu J, Cuvelier A, Muir JF. AVAPS-AE versus ST mode: A randomized controlled trial in patients with obesity hypoventilation syndrome. Respirology. 2020 Oct;25(10):1073-1081. doi: 10.1111/resp.13784. Epub 2020 Feb 13.
PubMed 32052923Magdy DM, Metwally A. Effect of average volume-assured pressure support treatment on health-related quality of life in COPD patients with chronic hypercapnic respiratory failure: a randomized trial. Respir Res. 2020 Mar 6;21(1):64. doi: 10.1186/s12931-020-1320-7.
PubMed 32143652Crisafulli E, Manni G, Kidonias M, Trianni L, Clini EM. Subjective sleep quality during average volume assured pressure support (AVAPS) ventilation in patients with hypercapnic COPD: a physiological pilot study. Lung. 2009 Sep-Oct;187(5):299-305. doi: 10.1007/s00408-009-9167-1. Epub 2009 Aug 13.
PubMed 19672655Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815.
PubMed 16963680Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
PubMed 18633595Goren NZ, Sanci E, Ercan Coskun FF, Gursoylu D, Bayram B. Comparison of BPAP S/T and Average Volume-Assured Pressure Support Modes for Hypercapnic Respiratory Failure in the Emergency Department: A Randomized Controlled Trial. Balkan Med J. 2021 Sep;38(5):265-271. doi: 10.5152/balkanmedj.2021.20137.
PubMed 34462252Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med. 2013 Mar 12;13:12. doi: 10.1186/1471-2466-13-12.
PubMed 23497021Murphy PB, Davidson C, Hind MD, Simonds A, Williams AJ, Hopkinson NS, Moxham J, Polkey M, Hart N. Volume targeted versus pressure support non-invasive ventilation in patients with super obesity and chronic respiratory failure: a randomised controlled trial. Thorax. 2012 Aug;67(8):727-34. doi: 10.1136/thoraxjnl-2011-201081. Epub 2012 Mar 1.
PubMed 22382596
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
- ClinicalTrials.gov ID
- NCT06047405
- Acronym / sponsor ID
- 22-0745
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- AVAPS, BIPAP, Hypercapnic respiratory failure, Noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 28 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS and BIPAP S/T and hypothesize that AVAPS will result in a decreased length of stay in the ICU or on telemetry. Currently, noninvasive ventilation is the standard of care for hypercapnic respiratory failure. However, the most effective mode for patients with hypercapnic respiratory failure is unclear.
Detailed description
- Overall Study Design and Plan
This is a single center, randomized trial that will include a total of 100 adult subjects aged 18 or older with hypercapnic respiratory failure of all etiologies (i.e. "all comers"). The investigators will randomize patients in a single-blinded (patient blinded) fashion to BIPAP S/T or AVAPS during the duration of their hospitalization. The investigators will assess ABG at baseline, 1 hour after initial placement on BIPAP S/T or AVAPS, and between hours 24-48 of use. The investigators will record the pre-NIV pH and PaCO2, post-NIV pH and PaCO2, length of hospital stay in the medical ICU or telemetry unit, days on NIV, need for intubation (if occurred), transition to medical ICU care in patients who were initially admitted to telemetry, and in-hospital mortality. All collected laboratory data are already done as part of usual care for all patients placed on NIV when a patient is on the telemetry unit or medical ICU. The groups will undergo stratified randomization based on whether they are initially admitted to medical ICU or medical telemetry. Patients from medical ICU or telemetry units will be randomized to one of the following arms:
Arm 1: AVAPS mode Arm 2 2: BIPAP S/T mode
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients from medical ICU or telemetry units will be randomized to one of the following arms: Arm 1: AVAPS mode Arm 2: BIPAP S/T mode
| Arm | Type | Receives |
|---|---|---|
| Average Volume-Assured Pressure Support (AVAPS) | Active comparator | Device: Average Volume-Assured Pressure Support (AVAPS)Average Volume-Assured Pressure Support (AVAPS) setting on the noninvasive ventilator. The exact AVAPS setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response. |
| Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) | Active comparator | Device: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) setting on the noninvasive ventilator. The exact BIPAP S/T setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form directly by the patient; consent can also be obtained via a legal patient representative/health care proxy/surrogate
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Diagnosed with hypercapnic respiratory failure on admission (ABG)
- Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit
Key exclusion criteria (14 listed)
- Patients who require ventilation at predetermined tidal volumes
- Patients who require rapid and frequent IPAP adjustments to maintain a consistent tidal volume
- Age less than 18 years of age
- Currently intubated
- Chronic tracheostomy
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 |
|---|---|---|
| Average Volume-Assured Pressure Support (AVAPS)A setting on noninvasive ventilator that allows setting of maximum and minimum inspiratory pressure and sets a target tidal volume. The inspiratory pressure varies breath to breath to ensure pre-set tidal volume is delivered. | Device | Average Volume-Assured Pressure Support (AVAPS) |
| Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)A setting on noninvasive ventilator that allows setting of inspiratory pressure, inspiratory time, expiratory pressure, and backup rate to deliver variable tidal volumes. | Device | Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) |
Primary outcome
ICU length of stay of telemetry length of stay
Time frame: within one week of hospital discharge (5-7 days)
In patients admitted to the medical ICU, the primary endpoint is ICU length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge. In patients admitted to medical telemetry unit, the outcome is telemetry length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge.
12 secondary outcomes
Difference in PaCO2 value with NIV
Time frame: within 24-48 hours after noninvasive ventilation
Time to normalization of pH
Time frame: at the time of hospital discharge (an average of 5-7 days)
Normalization of pH
Time frame: at the time of hospital discharge (an average of 5-7 days)
Days on NIV
Time frame: within one week of hospital discharge (5-7 days)
Need for intubation
Time frame: within one week of hospital discharge (5-7 days)
Need for ICU stay
Time frame: within one week of hospital discharge (5-7 days)
Subgroup analysis (logistic regression or p-value) comparing outcomes 1- ICU or telemetry length of stay based on the underlying cause of hypercapnic respiratory failure
Time frame: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 2- difference in paCO2 reported as difference between groups (with p-value and/or standard deviation)
Time frame: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 4- time to normalization of pH reported as difference between groups (with p-value and/or standard deviation)
Time frame: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 5- days on NIV reported as difference between groups (with p-value and/or standard deviation)
Time frame: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 6- need for intubation reported as difference between groups (with p-value and/or standard deviation)
Time frame: through study completion, an average of 1 year
Subgroup analysis (logistic regression or p-value) comparing outcome 7- need for ICU stay reported as difference between groups (with p-value and/or standard deviation)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 30317536Briones-Claudett KH, Esquinas Rodriguez A, Briones-Claudett MH, Puga-Tejada M, Cabrera Banos MDP, Pazmino Duenas CR, Torres Herrera CI, Grunauer M. Use of noninvasive mechanical ventilation with pressure support guaranteed with average volume in de novo hypoxaemic respiratory failure. A pilot study. Anaesthesiol Intensive Ther. 2018;50(4):283-290. doi: 10.5603/AIT.a2018.0036. Epub 2018 Oct 14.
- Background: PubMed 32052923Patout M, Gagnadoux F, Rabec C, Trzepizur W, Georges M, Perrin C, Tamisier R, Pepin JL, Llontop C, Attali V, Goutorbe F, Pontier-Marchandise S, Cervantes P, Bironneau V, Portmann A, Delrieu J, Cuvelier A, Muir JF. AVAPS-AE versus ST mode: A randomized controlled trial in patients with obesity hypoventilation syndrome. Respirology. 2020 Oct;25(10):1073-1081. doi: 10.1111/resp.13784. Epub 2020 Feb 13.
- Background: PubMed 32143652Magdy DM, Metwally A. Effect of average volume-assured pressure support treatment on health-related quality of life in COPD patients with chronic hypercapnic respiratory failure: a randomized trial. Respir Res. 2020 Mar 6;21(1):64. doi: 10.1186/s12931-020-1320-7.
- Background: PubMed 19672655Crisafulli E, Manni G, Kidonias M, Trianni L, Clini EM. Subjective sleep quality during average volume assured pressure support (AVAPS) ventilation in patients with hypercapnic COPD: a physiological pilot study. Lung. 2009 Sep-Oct;187(5):299-305. doi: 10.1007/s00408-009-9167-1. Epub 2009 Aug 13.
- Background: PubMed 16963680Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815.
- Background: PubMed 18633595Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
- Results publication: PubMed 34462252Goren NZ, Sanci E, Ercan Coskun FF, Gursoylu D, Bayram B. Comparison of BPAP S/T and Average Volume-Assured Pressure Support Modes for Hypercapnic Respiratory Failure in the Emergency Department: A Randomized Controlled Trial. Balkan Med J. 2021 Sep;38(5):265-271. doi: 10.5152/balkanmedj.2021.20137.
- Results publication: PubMed 23497021Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med. 2013 Mar 12;13:12. doi: 10.1186/1471-2466-13-12.
- Results publication: PubMed 22382596Murphy PB, Davidson C, Hind MD, Simonds A, Williams AJ, Hopkinson NS, Moxham J, Polkey M, Hart N. Volume targeted versus pressure support non-invasive ventilation in patients with super obesity and chronic respiratory failure: a randomised controlled trial. Thorax. 2012 Aug;67(8):727-34. doi: 10.1136/thoraxjnl-2011-201081. Epub 2012 Mar 1.
- Individual participant dataSharing planned: No. Only researchers on involved in conducting the study will have access to the information collected in the study. 9.3 Data Handling and Record Keeping 9.3.1 Data Collection and Management All information accessed from the medical record will be de-identified. All data will be stored on an encrypted secure server, REDCap. 9.3.2 Confidentiality and Privacy Privacy will be protected as data will be collected within the Northwell Redcap data portal. All data will be de-identified prior to entry into REDCap. All communication between subjects and researchers will be conducted in a private setting.
Related trials for Hypercapnic Respiratory Failure
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
HFNC Versus NIV in Hypercapneic COPD Patients
COPD (Chronic Obstructive Pulmonary Disease)
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.
Margarita Oks, MD principal investigator
Lenox Hill Hospital/Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) in people with Hypercapnic Respiratory Failure, run by Northwell Health 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Velichkovikj ((212)-434-4087, svelichkovik@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay of telemetry length of stay (time frame: within one week of hospital discharge (5-7 days)). 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 NCT06047405, which also lists 9 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 31 Oct 2023.