Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Ms Gill Arbane
ORCID ID
Contact details
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
-
Gill.Arbane@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16392
Study information
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
Acronym
OPIP
Study hypothesis
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
NRES Committee London, Westminster, 27/05/2014, ref: 13/LO/1362
Study design
Randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2014
Overall trial end date
30/04/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size = 82, UK sample size = 62
Participant 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
Recruitment start date
01/07/2014
Recruitment end date
01/04/2016
Locations
Countries of recruitment
France, Switzerland, United Kingdom
Trial participating centre
St Thomas's Hospital
London
SE1 7EH
United Kingdom
Trial participating centre
St James' Hospital
Leeds
LS9 7TF
United Kingdom
Trial participating centre
Royal Brompton Hospital
London
SW3 6NP
United Kingdom
Trial participating centre
Royal Free Hospital
NW3 2QG
United Kingdom
Trial participating centre
University Hospital of Grenoble
Grenoble
38700
France
Trial participating centre
University Hospital of Rouen
76000
France
Funders
Funder type
Industry
Funder name
Philips Respironics Inc (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan publication in a high-impact peer reviewed journal in April 2019.
IPD sharing statement
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.
Intention to publish date
01/04/2019
Participant level data
Other
Results - basic reporting
Publication summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25908673