Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure (OPIP)
Primary Purpose
Obesity Hypoventilation Syndrome, Chronic Respiratory Failure
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)
Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome
Eligibility Criteria
Inclusion Criteria:
- Obese patients with chronic respiratory failure
- Age > 18 years
- Chronic hypercapnia (daytime PaCO2 > 6.0kPa)
- Evidence of sleep disordered breathing on overnight oximetry study (4% oxygen desaturation index >10events per hour and/or >30% of the total analysis time with an SpO2 < 90%)
- Patients with a recent acute episode requiring non-invasive ventilation will need a minimum of 2 weeks stability prior to enrolment into the trial (no NIV requirement for 2 weeks and pH (Inverse logarithm of hydrogen ion concentration) ≥ 7.3)
- BMI ≥ 35kg/m2
- FEV1/FVC (Forced Expiratory Volume at 1 second/Forced Vital Capacity) > 70%
Exclusion Criteria:
- Persistent hypercapnic respiratory acidosis defined as pH <7.30
- Severe hypoxic and/or hypercapnic respiratory failure defined as a PaO2 (Partial Pressure of Oxygen)< 7.0kPa and/or a PaCO2 > 9kPa (kilopascal)
- Failure to tolerate NIV during initiation or if required to treat acute decompensation
- Hypercapnic respiratory failure requiring intubation within the last 28 days
- Hypercapnic respiratory failure secondary to an identifiable cause other than obesity
- Acute coronary syndrome or unstable angina
- Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol
- Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
- Patients undergoing renal replacement therapy
- Patients with co-existent cancer and a prognosis likely to be less than 12-months
- Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres)
- Stroke with hemiparesis
- Age <18 years
- Pregnant
Sites / Locations
- Hôpital Universitaire, de Grenoble
- Rouen University Hospital
- Leeds Teaching Hospital NHS Foundation Trust
- Royal Free Hospital
- Guys and St Thomas NHS Foundation
- Royal Brompton and Harefield NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Goup
Intervention Group
Arm Description
Inpatient initiation of noninvasive ventilation.
Initiated on NIV during an elective outpatient clinic review during which an arterial blood gas measurement will be obtained to confirm the presence of chronic respiratory failure.
Outcomes
Primary Outcome Measures
Medium Term Cost-Effectiveness
To evaluate the medium term cost effectiveness of outpatient non-invasive ventilation set-up with an automated device compared with inpatient nurse-led protocolised fixed level non-invasive ventilation set-up in obese patients with chronic respiratory failure at 3 months
Secondary Outcome Measures
Health Related Quality of Life
To evaluate the health related quality of life improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months
Gas Exchange Improvements
To evaluate the gas exchange improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months.
Full Information
NCT ID
NCT02342899
First Posted
January 13, 2015
Last Updated
February 6, 2020
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Philips Electronics Nederland B.V. acting through Philips CTO organization
1. Study Identification
Unique Protocol Identification Number
NCT02342899
Brief Title
Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure
Acronym
OPIP
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Philips Electronics Nederland B.V. acting through Philips CTO organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 (breathlessness)and enhances quality of life. NIV has also shown to increase physical activity (using actigraphy)and there can be associated weight reduction after three months of initiation.
Currently, the length of an inpatient stay for NIV set up is between 4.5 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome, Chronic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Goup
Arm Type
Active Comparator
Arm Description
Inpatient initiation of noninvasive ventilation.
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Initiated on NIV during an elective outpatient clinic review during which an arterial blood gas measurement will be obtained to confirm the presence of chronic respiratory failure.
Intervention Type
Device
Intervention Name(s)
Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)
Intervention Description
Intervention set ups will follow a standard protocol for the automated device (A40 AVAPS-AE machine;Manufactured by Philips-Respironics, Murraysville, Pittsburgh, US) and patients will be discharged with the machine and a full face mask or nasal interface. Patients will then undergo a 1-2 night home oximetry study to ensure adequate control of overnight oxygenation. Patients will be reviewed clinically as an outpatient at 6 weeks and adherence to non-invasive ventilation will be evaluated and an arterial blood gas measurement will be undertaken. A full clinical review and optimisation of NIV and interface will be performed at this visit. Patients will be reviewed at 3 months as an inpatient where overnight transcutaneous carbon dioxide level and SpO2 studies will be performed. All other patient-centred, physician-centred and healthcare utilisation measurements will be assessed at baseline, 6 weeks and 3 months.
Intervention Type
Device
Intervention Name(s)
Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)
Intervention Description
The patient will follow a specialist nurse-led protocolised set up of spontaneous/timed (S/T) mode pressure support ventilation (A40 AVAPS-AE machine; Manufactured by Philips-Respironics, Murraysville, Pittsburgh, US) using limited respiratory polygraphy, including overnight TcCO2 (Trascutaneous Carbon Dioxide) and SpO2 (Oxygen Saturation) studies. Following the inpatient set-up, patients will be reviewed as an outpatient at 6 weeks and adherence with non-invasive ventilation will be evaluated and arterial blood gas measurements will be performed. Patients will then be reviewed at 3 months as an inpatient where overnight respiratory polygraphy, TcCO2 and SpO2 studies will be repeated. All other patient-centred, physician-centred measurements and healthcare utilisation measurements will be assessed at baseline, 6 weeks and 3 months.
Primary Outcome Measure Information:
Title
Medium Term Cost-Effectiveness
Description
To evaluate the medium term cost effectiveness of outpatient non-invasive ventilation set-up with an automated device compared with inpatient nurse-led protocolised fixed level non-invasive ventilation set-up in obese patients with chronic respiratory failure at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
To evaluate the health related quality of life improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months
Time Frame
3 months
Title
Gas Exchange Improvements
Description
To evaluate the gas exchange improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obese patients with chronic respiratory failure
Age > 18 years
Chronic hypercapnia (daytime PaCO2 > 6.0kPa)
Evidence of sleep disordered breathing on overnight oximetry study (4% oxygen desaturation index >10events per hour and/or >30% of the total analysis time with an SpO2 < 90%)
Patients with a recent acute episode requiring non-invasive ventilation will need a minimum of 2 weeks stability prior to enrolment into the trial (no NIV requirement for 2 weeks and pH (Inverse logarithm of hydrogen ion concentration) ≥ 7.3)
BMI ≥ 35kg/m2
FEV1/FVC (Forced Expiratory Volume at 1 second/Forced Vital Capacity) > 70%
Exclusion Criteria:
Persistent hypercapnic respiratory acidosis defined as pH <7.30
Severe hypoxic and/or hypercapnic respiratory failure defined as a PaO2 (Partial Pressure of Oxygen)< 7.0kPa and/or a PaCO2 > 9kPa (kilopascal)
Failure to tolerate NIV during initiation or if required to treat acute decompensation
Hypercapnic respiratory failure requiring intubation within the last 28 days
Hypercapnic respiratory failure secondary to an identifiable cause other than obesity
Acute coronary syndrome or unstable angina
Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol
Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
Patients undergoing renal replacement therapy
Patients with co-existent cancer and a prognosis likely to be less than 12-months
Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres)
Stroke with hemiparesis
Age <18 years
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Hart
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Universitaire, de Grenoble
City
Grenoble
ZIP/Postal Code
Cedex 9
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Leeds Teaching Hospital NHS Foundation Trust
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS2 9LN
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Royal Brompton and Harefield NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data
Citations:
PubMed Identifier
36342884
Citation
Murphy PB, Patout M, Arbane G, Mandal S, Kaltsakas G, Polkey MI, Elliott M, Muir JF, Douiri A, Parkin D, Janssens JP, Pepin JL, Cuvelier A, Flach C, Hart N. Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial. Thorax. 2023 Jan;78(1):24-31. doi: 10.1136/thorax-2021-218497. Epub 2022 Sep 2.
Results Reference
derived
Learn more about this trial
Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure
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