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

Обзор

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.

Подробное описание

1\. 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

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• ICU length of stay of telemetry length of stay [Срок оценки: within one week of hospital discharge (5-7 days)]

Вторичные конечные точки (12)

• Difference in PaCO2 value with NIV [Срок оценки: within 24-48 hours after noninvasive ventilation]
• Time to normalization of pH [Срок оценки: at the time of hospital discharge (an average of 5-7 days)]
• Normalization of pH [Срок оценки: at the time of hospital discharge (an average of 5-7 days)]
• Days on NIV [Срок оценки: within one week of hospital discharge (5-7 days)]
• Need for intubation [Срок оценки: within one week of hospital discharge (5-7 days)]
• Need for ICU stay [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Lenox Hill Hospital — New York

Публикации

• 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
• 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 1 PMID 32052923
• 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
• 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
• 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
• 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
• 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
• 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 PMID 23497021

Идентификаторы

NCT: NCT06047405 · 22-0745

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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