NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP

NCT06047405 | Recruiting DMC FDA Device

• 1 other identifier: 22-0745
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypercapnic Respiratory Failure

Keywords

AVAPS; BIPAP; Hypercapnic respiratory failure; Noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  within one week of hospital discharge (5-7 days)

Secondary Outcomes (12)

• Difference in PaCO2 value with NIV

  within 24-48 hours after noninvasive ventilation

• Time to normalization of pH

  at the time of hospital discharge (an average of 5-7 days)

• Normalization of pH

  at the time of hospital discharge (an average of 5-7 days)

• Days on NIV

  within one week of hospital discharge (5-7 days)

• Need for intubation

  within one week of hospital discharge (5-7 days)

Study Arms (2)

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.

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.

Device: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)

Interventions

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.

Average Volume-Assured Pressure Support (AVAPS)

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.

Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 30317536 BACKGROUND

• Patout 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.

  PMID: 32052923 BACKGROUND

• Magdy 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.

  PMID: 32143652 BACKGROUND

• Crisafulli 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.

  PMID: 19672655 BACKGROUND

• Storre 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.

  PMID: 16963680 BACKGROUND

• Rose 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.

  PMID: 18633595 BACKGROUND

• Goren 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.

  PMID: 34462252 RESULT

• Briones 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.

  PMID: 23497021 RESULT

• Murphy 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.

  PMID: 22382596 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Margarita Oks, MD

  Lenox Hill Hospital/Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Velichkovikj

CONTACT

(212)-434-4087; svelichkovik@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 21, 2023
• Study Start: October 7, 2023
• Primary Completion: September 28, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)