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 disease
| ISRCTN | ISRCTN51420481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51420481 |
| IRAS number | 139750 |
| ClinicalTrials.gov number | NCT02342899 |
| Secondary identifying numbers | 16392; IRAS 139750 |
- Submission date
- 12/06/2014
- Registration date
- 12/06/2014
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Patients with obesity and breathing failure often require a mask overnight to help them breathe. At present, the length of hospital stay for such mask ventilation [Non Invasive Ventilation (NIV)] is between 4.5 and 6 days. There is no evidence to support the clinical or cost effectiveness of setting up mask ventilation on an outpatient basis in the clinic, compared to inpatient set-up on the ward by specialist respiratory nurses, although this is increasingly used as a strategy in smaller units without inpatient facilities. In essence, financial constraints are driving a practice that has no current evidence base in this patient group. Obese patients with long-term respiratory failure have complex physiological changes and often require much higher mask ventilation pressures than other patients needing hospital admission to gain control of their sleep disordered breathing. This will be the first study to test whether outpatient set-up mask ventilation in obese patients with chronic respiratory failure is clinically effective and cost effective at 3 months.
Who can participate?
Stable obese patients attending for management of chronic respiratory failure related to obesity.
What does the study involve?
Patient are randomly allocated to one of two groups: intervention and standard treatment. Intervention group patients are initiated on NIV during an optional outpatient clinic review during which an arterial blood gas measurement (from the wrist) is taken to confirm the presence of long-term respiratory failure. Patients in the standard treatment group are admitted for an inpatient initiation of NIV.
What are the possible benefits and risks of participating?
By taking part in the research, participants are helping shape the future management of patients with the same condition. All of the other research tests are not invasive so there will be no direct risk to participants.
Where is the study run from?
1. St Thomas' Hospital, London, UK (lead site)
2. St James' Hospital, Leeds, UK
3. Royal Brompton Hospital, London, UK
4. Royal Free Hospital, London, UK
5. University Hospital of Grenoble, France
6. University Hospital of Rouen, France
When is the study starting and how long is it expected to run for?
April 2014 to April 2018
Who is funding the study?
Phillips Respironics (UK)
Who is the main contact?
Gill Arbane (Project Coordinator)
gill.arbane@gstt.nhs.uk
Contact information
Scientific
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Gill.Arbane@gstt.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 disease: a randomised controlled trial |
| Study acronym | OPIP |
| Study objectives | The OPIP Trial will be a randomised controlled trial by an international group to evaluate the cost effectiveness on an automated non-invasive ventilation outpatient set up vs. standard fixed level non-invasive ventilation inpatient set up (mask ventilation) for initiation for obese patients with chronic respiratory failure. OPIP will evaluate standard treatment costs and patients health related quality of life and change in a gas exchange. |
| Ethics approval(s) | Current ethics approval as of 10/02/2020: Approved 27/05/2014, NRES Committee London- Westminster (Bristol REC Centre Level 3, Block B, Whitefriars Lewins Mead, Bristol, BS1 2NT; +44 0117 342 138; nrescommittee.london-westminster@nhs.net), ref: 14/LO/0414 Previous ethics approval: NRES Committee London, Westminster, 27/05/2014, ref: 13/LO/1362 |
| Health condition(s) or problem(s) studied | Topic: Metabolic and endocrine disorders, Respiratory disorders; Subtopic: Metabolic and Endocrine (all Subtopics), Respiratory (all Subtopics); Disease: Metabolic & Endocrine (not diabetes), Respiratory |
| Intervention | A randomised controlled trial of Outpatient vs Inpatient NIV Set Up, randomised by site, gender and previous mask use, to determine clinical and cost effectiveness of outpatient set up. All patients will keep a record of Health Care Utilisation and be followed up with telephone calls from the research team throughout the trial. Patients will be seen at baseline, 6 weeks and 3 months, primary outcome measure will be cost effectiveness. |
| Intervention type | Other |
| Primary outcome measure | Cost effectiveness of standard treatment costs and health related quality of life (SRI and Eq-5D); Timepoint(s): Baseline, 6 weeks and 3 months |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2014 |
| Completion date | 30/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size = 82, UK sample size = 62 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Obese patients with chronic respiratory failure 2. Age >18 years 3. Chronic hypercapnia (daytime pCO2>6.5kPa) 4. Evidence of sleep disordered breathing on overnight oximetry study (4% oxygen desaturation index>10 events per hour and/or >30% of the total analysis time with an SpO2 <90%) 5. BMI>35kg/m2 6. FEV1/FVC>70% 7. Tolerates NIV>4 hours on first night during initiation of NIV |
| Key exclusion criteria | 1. Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30) 2. Severe hypoxic and/or hypercapnic respiratory failure defined as PaO2<7.0kPa and/or PaCO2>9kPa 3. Failure to tolerate NIV during initiation or if required to treat acute decompensation 4. Prior acute hypercapnic respiratory failure requiring intubation 5. Hypercapnic respiratory failure secondary to an identifiable cause other than obesity 6. Unstable coronary artery syndrome 7. Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol 8. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge 9. Patients undergoing renal replacement therapy 10. Patients with co-existent cancer and a prognosis likely to be less than 12-months 11. Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres) 12. Stroke with hemiparesis 13. Age <18 years 14. Pregnant |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 01/04/2016 |
Locations
Countries of recruitment
- England
- France
- Switzerland
- United Kingdom
Study participating centres
SE1 7EH
United Kingdom
LS9 7TF
United Kingdom
SW3 6NP
United Kingdom
United Kingdom
38700
France
France
Sponsor information
Hospital/treatment centre
Department of Immunology
London
SE1 7EH
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Plan publication in a high-impact peer reviewed journal in April 2019. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/04/2015 | Yes | No | |
| Results article | 02/09/2022 | 08/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/02/2020: The following changes have been made:
1.The ethics approval has been updated.
2. The IRAS number has been added.
12/05/2017: Switzerland was removed from the countries of recruitment.
04/04/2017: The overall trial end date was changed from 01/04/2016 to 30/04/2018.
