NCT06047405 · Northwell Health
NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
What this study is about
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 the usual treatment for hypercapnic respiratory failure.
View original scientific description
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.
Interventions
DEVICE
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
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2023 · Source of record for eligibility and locations