Astral VAPS AutoEPAP Clinical Trial

Respiratory Failure Clinical Trial

Official title:

The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683772
• Other study ID #: MA-15-12-15
• Status: Completed
• Phase: Phase 3
• Start date: April 15, 2016
• Est. completion date: July 6, 2017

Study information

• Verified date: July 2019
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 6, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency
• Upper Airway Obstruction

Intervention

Device:
• Astral
Astral ventilator

Locations

Country	Name	City	State
United States	Lisa F. Wolfe, MD	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	University of California, San Diego	La Jolla	California
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

References & Publications (5)

Budweiser S, Jörres 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. — View Citation

Laghi F, Tobin MJ. Disorders of the respiratory muscles. Am J Respir Crit Care Med. 2003 Jul 1;168(1):10-48. Review. — View Citation

Masa JF, Celli BR, Riesco JA, Hernández M, Sánchez De Cos J, Disdier C. The obesity hypoventilation syndrome can be treated with noninvasive mechanical ventilation. Chest. 2001 Apr;119(4):1102-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Desaturation Index 4% (ODI4%)	Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP	Overnight, up to 8 hrs on nights 1 and 2
Secondary	Sleep Efficiency (%)	To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)	Overnight, up to 8 hrs on nights 1 and 2
Secondary	Apnea Hypopnea Index (AHI)	To assess sleep-breathing parameters between groups using mean AHI (#events/hour)	Overnight, up 8 hrs on night 1 and 2
Secondary	Nadir Arterial Oxygen Saturation (SpO2)	To assess Sleep-breathing parameters between groups using mean SpO2 (%)	Overnight, up 8 hrs on night 1 and 2
Secondary	Arterial Carbon Dioxide (PCO2)	To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)	Overnight, up 8 hrs on night 1 and 2