Condition category
Respiratory
Date applied
12/06/2014
Date assigned
12/06/2014
Last edited
27/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 will be initiated on NIV during an optional outpatient clinic review during which an arterial blood gas measurement (from the wrist) will be taken to confirm the presence of long-term respiratory failure. Patients in the standard treatment group will be 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. University Hospital of Geneva, Switzerland
5. University Hospital of Grenoble, France

When is study starting and how long is it expected to run for?
The study started in April 2014 and is expected to run until March 2016.

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 below 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

01/04/2016

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

University Hospital of Geneva
Geneva
1205
Switzerland

Trial participating centre

University Hospital of Grenoble
Grenoble
38700
France

Sponsor information

Organisation

Guy's and St. Thomas' NHS Foundation trust (UK)

Sponsor details

Department of Immunology
London
SE1 7EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25908673

Publication citations

Additional files

Editorial Notes