AVAPS-AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD)Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— AVAPS-AE COPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01611870
• Other study ID #: HRC-1119-AVAPSAECOPD-SS
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2012
• Last updated: June 4, 2012
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD patients during nocturnal ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years

• Diagnosis of COPD

• Currently using a Bilevel device

• 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 leg syndrome (PLMI > 10)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• AVAPS-AE
AVAPS-AE is the experimental ventilation mode of therapy in this study that includes a combination of already cleared therapy attributes.
• AVAPS-AE mode of ventilator therapy
All participants will use the study device in the titrated to the AVAPS-AE mode of ventilator therapy for six weeks of home use.

Locations

Country	Name	City	State
United Kingdom	NIHR Comprehensive Biomedical Research Center	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TCO2 measurement from baseline to 2 weeks post AVAPS-AE mode of therapy and change in TCO2 measurement from baseline to 6 weeks post AVAP-AE mode of therapy	The baseline bilevel sleep study data and the AVAPS-AE sleep study data (from Baseline, 2 week and 6 week visits) will be analyzed to ascertain adequate control of nocturnal ventilation via mean overnight TcCO2 measurements.	Baseline study, 2 week study and after 6 weeks of therapy	No
Secondary	Actigraphy	Monitors activity during the day and sleep	2 weeks prior to the Baseline Sleep study	No
Secondary	Six Minute Walk test	Six minute walk test will assess total distance walked, pre/post Borg dyspnea scale ratings and overall fatigue ratings.	Baseline, 2 week and 6 week measurements	No
Secondary	Spirometry	Spirometry will assess flow rates for breathing manuevers.	Baseline, 2 week and 6 week measurements	No
Secondary	Nocturnal Capnography (TcC02)		Baseline, 2 week and 6 week measurements	No
Secondary	Nocturnal oximetry (Sp02)	oximetry testing to monitor oxygen saturation during sleep studies	Baseline, 2 week and 6 week measurements	No
Secondary	Daily Sleep Log		During the initial 14 days of AVAPS-AE therapy at home	No
Secondary	Severe Respiratory Insufficiency Questionnaire		Baseline, 2 week and 6 week visits	No
Secondary	COPD Assessment Test- CAT		Baseline, 2 week and 6 week visits	No
Secondary	MRC Dyspnea Questionnaire		Baseline, 2 week and 6 week visits	No