Obesity Hypoventilation SyndromePhase 3OPIPNCT02342899
Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure
A Phase 3 study testing Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics) and Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics) in people with Obesity Hypoventilation Syndrome and Chronic Respiratory Failure, run by Guy's and St Thomas' NHS Foundation Trust at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome, Chronic Respiratory Failure
- What is being tested?
- Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics) and Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Mar 2015to 30 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom4 sites
Leeds Teaching Hospital NHS Foundation Trust
Leeds, Yorkshire, LS2 9LN
Royal Free Hospital
London, NW3 2QG
Guys and St Thomas NHS Foundation
London, SE1 7EH
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
France2 sites
Hôpital Universitaire, de Grenoble
Grenoble, Cedex 9
Rouen University Hospital
Rouen, 76000
About this study
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
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.
Read the 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.
- Being tested
- 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)
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)Device
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.
Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Goup | Active comparator | Inpatient initiation of noninvasive ventilation. Receives: Device: Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics) |
| Intervention Group | Active comparator | 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. Receives: Device: Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start1 Mar 2015
- Primary completion30 Jun 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Sponsor
- Investigators
- Nick Hart, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342899
- Sponsor's protocol ID
- 139750
- Acronym
- OPIP
- Status last verified
- Feb 2020
- First submitted
- 13 Jan 2015
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share individual participant data
Publications
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.
PubMed 36342884
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02342899
- Acronym / sponsor ID
- OPIP / 139750
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Goup | Active comparator | Device: Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)Inpatient initiation of noninvasive ventilation. |
| Intervention Group | Active comparator | Device: Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)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. | Device | Intervention Group |
| Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)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. | Device | Control Goup |
Primary outcome
Medium Term Cost-Effectiveness
Time frame: 3 months
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
2 secondary outcomes
Health Related Quality of Life
Time frame: 3 months
Gas Exchange Improvements
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 36342884Murphy 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.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Hart principal investigator
Guy's and St Thomas' NHS Foundation Trust
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics) and Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics) in people with Obesity Hypoventilation Syndrome and Chronic Respiratory Failure, run by Guy's and St Thomas' NHS Foundation Trust at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medium Term Cost-Effectiveness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.