Clinical trial NCT02683772: Astral VAPS AutoEPAP Clinical Trial
Official title: The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Airway Obstruction
Respiratory Insufficiency
Respiratory Failure
Keywords: NIV, NIPPV, ventilation
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-02-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.


Eligibility criteria: Inclusion criteria for the study are:

1. Participant has ability to provide written informed consent
2. Participants aged ≥18 years old
3. Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg)
4. Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months
5. Participants with a previously documented AHI ≥ 5/hr
6. Participants with a recently (≤ 12 months ago) reviewed EPAP setting

Exclusion criteria for the study are:

1. Participants are not compliant on NIPPV (e.g. \< 4 hr/night)
2. Participants who are pregnant
3. Participants on oxygen therapy ≥5 L/min
4. Participants with an invasive interface (e.g. tracheostomy)
5. Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation
6. Participants who are acutely ill, medically complicated or who are medically unstable
7. Participants in whom NIPPV therapy is otherwise medically contraindicated
8. Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
9. Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
10. Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma.
11. Participant does not comprehend English
12. Participant is unable or unwilling to provide written informed consent
13. Participant is physically and/or mentally unable to comply with the protocol
14. Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator

Primary outcomes:
measure: Oxygen Desaturation Index 4% (ODI4%)
timeFrame: Overnight, up to 8 hrs on nights 1 and 2
Secondary outcomes:
measure: Sleep Efficiency (%)
timeFrame: Overnight, up to 8 hrs on nights 1 and 2
measure: Apnea Hypopnea Index (AHI)
timeFrame: Overnight, up 8 hrs on night 1 and 2
measure: Nadir Arterial Oxygen Saturation (SpO2)
timeFrame: Overnight, up 8 hrs on night 1 and 2
measure: Arterial Carbon Dioxide (PCO2)
timeFrame: Overnight, up 8 hrs on night 1 and 2
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: Lisa F. Wolfe, MD
state: Illinois
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Northwestern Medical Center
name: Lisa Wolfe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Budweiser S, Jorres RA, Riedl T, Heinemann F, Hitzl AP, Windisch W, Pfeifer M. Predictors of survival in COPD patients with chronic hypercapnic respiratory failure receiving noninvasive home ventilation. Chest. 2007 Jun;131(6):1650-8. doi: 10.1378/chest.06-2124.
citation: Masa JF, Celli BR, Riesco JA, Hernandez M, Sanchez De Cos J, Disdier C. The obesity hypoventilation syndrome can be treated with noninvasive mechanical ventilation. Chest. 2001 Apr;119(4):1102-7. doi: 10.1378/chest.119.4.1102.
citation: Remmers JE, deGroot WJ, Sauerland EK, Anch AM. Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol. 1978 Jun;44(6):931-8. doi: 10.1152/jappl.1978.44.6.931. No abstract available.
citation: Ward S, Chatwin M, Heather S, Simonds AK. Randomised controlled trial of non-invasive ventilation (NIV) for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia. Thorax. 2005 Dec;60(12):1019-24. doi: 10.1136/thx.2004.037424.
citation: Laghi F, Tobin MJ. Disorders of the respiratory muscles. Am J Respir Crit Care Med. 2003 Jul 1;168(1):10-48. doi: 10.1164/rccm.2206020.
citation: Suh ES, Murphy PB. Auto-titration of EPAP during NIV: A better night's sleep? Respirology. 2019 Dec;24(12):1132-1133. doi: 10.1111/resp.13587. Epub 2019 May 23. No abstract available.
citation: Orr JE, Coleman J, Criner GJ, Sundar KM, Tsai SC, Benjafield AV, Crocker ME, Willes L, Malhotra A, Owens RL, Wolfe LF. Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial. Respirology. 2019 Dec;24(12):1204-1211. doi: 10.1111/resp.13546. Epub 2019 Apr 22.