Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD) Patients

COPD Clinical Trial

— AVAPS AE  

Official title:

Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease: A Non-randomised Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01601977
• Other study ID #: AVAPS AE in COPD
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 17, 2012
• Last updated: May 22, 2012
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Patrick B Murphy, MBBS
• Phone: 02071888070
• Email: patrickmurphy1[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

COPD continues to be a cause of major morbidity for patients. Those patients who also have respiratory failure are at higher risk of exacerbations and death and have worse health related quality of life than similar COPD patients without respiratory failure.

Treatment options in this group of patients have been limited and data to support the use of machines to assist breathing (non-invasive ventilators) in stable patients are limited. A major limitation of these devices has been patient acceptance and achieving sufficient control of sleep breathing disturbance.

Currently devices are set at a fixed pressure to support the breathing throughout the night. The new software within the trial device will aim to better match the support provided by the machine to that needed by the patient. It is hoped that this may offer enhanced comfort as well as superior control of respiratory failure.

Description:

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide.

Treatment options for COPD patients consist of medications, such as bronchodilators and anti-inflammatory drugs, pulmonary rehabilitation, long term oxygen therapy (LTOT), lung volume reduction surgery and lung transplantation. Studies have shown that bronchodilators and anti-inflammatory drugs show minor or no benefit on long term outcomes but rather are used mainly for symptomatic relief.1 Pulmonary rehabilitation has been demonstrated to improve functional status and symptoms but there is lacking evidence on long term outcomes of this therapy. 2 Lung volume reduction surgery and lung transplantation is only appropriate for a small number of patients; therefore, there is no demonstration of improved long-term survival rate.3, 4

Of these available therapies, few have been shown to significantly improve long term patient outcomes. For the severe COPD patient, LTOT is the only treatment that demonstrated prolonged survival in controlled studies. 5, 6 But, despite the effectiveness of LTOT, COPD is still characterized by a high morbidity and mortality rate.

Noninvasive positive pressure ventilation (NPPV) is one therapy that may prove beneficial to stable COPD patients. NPPV is the use of positive pressure ventilation administered via a nasal or full face mask (that covers both the nose and mouth). This type of ventilation has become a well established and increasingly used therapeutic option for patients with hypercapnic respiratory failure (HRF) due to COPD.7

NPPV, used nocturnally, may improve nighttime hypoventilation that is common with COPD patients. An improvement in nocturnal hypoventilation would reset the respiratory center sensitivity for CO2.8 9 This would result in an improvement in daytime gas exchange and sleep quality. It is also known that hyperinflation in patients with COPD increases their work of breathing, thus fatiguing the respiratory muscles.10 It has been suggested that by applying nocturnal NPPV it would allow the respiratory muscles to rest, resulting in muscle function recovery, increased muscle strength, reduced tendency for fatigue and improvement in pulmonary function and gas exchange.11

AVAPS AE AVAPS AE is a mode of therapy (Philips Respironics Inc, Monroeville, PA, USA) with potential advantages over the currently established modes of noninvasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), AutoEPAP and Auto Back up Rate. In this study, we are evaluating the AVAPS AE mode as compared to the participant's current mode of ventilation. We believe that these automated parameters will allow better nocturnal ventilatory control to offset the differing elastic and resistive loads imposed by changes in body position during sleep. Furthermore, AVAPS AE will counter the changing ventilatory requirements due to alterations in lung volumes and airway resistance during different stages of sleep. In summary, the AVAPS AE mode will enable automatic adjustment in response to ventilatory changes throughout the night.

Study Objective The objective of this study is to validate the performance of the AVAPS AE therapy in COPD patients during nocturnal ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age = 21

• Diagnosis of COPD

• Currently using Bilevel device

• Ability to provide consent

• Documentation of medical stability by PI

Exclusion Criteria:

• Subjects, who are acutely ill, medically complicated or who are medically unstable.

• Subjects in whom PAP therapy is otherwise medically contraindicated.

• Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.

• Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Omnilab - AVAPS AE algorithm
Nocturnal NIV via Omnilab device using the AVAPS AE algorithm
• Usual care
usual care

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Patrick Murphy	Philips Respironics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	control of nocturnal hypoventilation	transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device	6 week assessment	No
Secondary	Health related quality of life	SRI questionnaire, CAT score, Epworth score, MRC dyspnoea score	2 weeks	No
Secondary	Health related quality of life	SRI questionnaire, CAT score, Epworth score, MRC dyspnoea score	6 weeks	No
Secondary	Sleep disruption	Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST, sleep stage distibution, arousal index, AHI	6 weeks	No
Secondary	control of nocturnal hypoventilation	overnight limited respiratory sleep study examining mean SpO2, min SpO2, max tcCO2, 4%ODI	2 weeks	No
Secondary	Assessment of nocturnal hypoventilation	overnight limited respiratory sleep study examining mean SpO2, min SpO2, max tcCO2, 4%ODI	6 weeks	No
Secondary	Exercise capacity	6 minute walk test	6 weeks	No
Secondary	Exacerbation frequency	patient reported exacerbations following 6 weeks of device usage	6 weeks	Yes