Ignite Creation Date:
2024-05-06 @ 3:39 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02342899
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2015-01-13
Brief Title:
Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Medium Cost Effectiveness of Automated Non-Invasive Ventilation Outpatient Set Up vs Standard Fixed Level Non-Invasive Ventilation Inpatient Set Up In Obese Patients With Chronic Respiratory Failure
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPIP
Brief Summary:
Obesity is an escalating issue with an accompanying increase in referrals of patients with obesity-related respiratory failure Currently these patients are electively admitted to hospital for initiation of non-invasive ventilation NIV but it is unknown whether outpatient initiation is as effective as inpatient set-up The investigators hypothesise that outpatient set up using an auto-titrating NIV device will be more cost effective than nurse-led inpatient titration and set-up
The investigators will undertake a multi-national multi-centre randomised controlled trial
Subjects will be randomised to receiving usual inpatient set-up which will include nurse-led initiation of NIV or outpatient set-up with an automated NIV device Subjects will be stratified according to trial site gender and previous use of NIV or continuous positive airway pressure Assuming 10 drop out rate a total sample of 82 patients will be required Cost effectiveness will be evaluated using standard treatment costs and health service utilisation and using health related quality of life measures SRI and EQ5D Change in the severe respiratory insufficiency SRI questionnaire will be based on analysis of covariance ANCOVA adjusting for the baseline measurements between the two arms of patients
The investigators will undertake a multi-national multi-centre randomised controlled trial
Subjects will be randomised to receiving usual inpatient set-up which will include nurse-led initiation of NIV or outpatient set-up with an automated NIV device Subjects will be stratified according to trial site gender and previous use of NIV or continuous positive airway pressure Assuming 10 drop out rate a total sample of 82 patients will be required Cost effectiveness will be evaluated using standard treatment costs and health service utilisation and using health related quality of life measures SRI and EQ5D Change in the severe respiratory insufficiency SRI questionnaire will be based on analysis of covariance ANCOVA adjusting for the baseline measurements between the two arms of patients
Detailed Description:
There is an increase of patients with hypercapnic respiratory failure as a consequence of obesity The current treatment options for patients with obesity related respiratory failure is non-invasive ventilation NIV This has shown to reduce partial pressure of arterial carbon dioxide PaCO2 and improves symptoms such as dyspnea breathlessnessand enhances quality of life NIV has also shown to increase physical activity using actigraphyand there can be associated weight reduction after three months of initiation
Currently the length of an inpatient stay for NIV set up is between 45 and 6 days As yet it is unknown whether or not a patient can be set up onto NIV as effectively on an outpatient basis using an AE-AVAPS Automatic Expiratory Positive Airway Pressure - Average Volume Assured Pressure Support algorithm compared to the usual practice of inpatient titration by specialist respiratory nurses Furthermore the cost effectiveness of outpatient initiation vs inpatient initiation is unknown in this group of patients
This will be the first trial to assess the cost effectiveness of such a set up
Currently the length of an inpatient stay for NIV set up is between 45 and 6 days As yet it is unknown whether or not a patient can be set up onto NIV as effectively on an outpatient basis using an AE-AVAPS Automatic Expiratory Positive Airway Pressure - Average Volume Assured Pressure Support algorithm compared to the usual practice of inpatient titration by specialist respiratory nurses Furthermore the cost effectiveness of outpatient initiation vs inpatient initiation is unknown in this group of patients
This will be the first trial to assess the cost effectiveness of such a set up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None