NCT02342899

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Typical duration for phase_3

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

3.3 years

First QC Date

January 13, 2015

Last Update Submit

February 6, 2020

Conditions

Obesity Hypoventilation SyndromeChronic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (2)

  • Health Related Quality of Life

    3 months

  • Gas Exchange Improvements

    3 months

Study Arms (2)

Control Goup

ACTIVE COMPARATOR

Inpatient initiation of noninvasive ventilation.

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.

Device: Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)

Interventions

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.

Intervention Group
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.

Control Goup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Universitaire, de Grenoble

Grenoble, Cedex 9, France

Location

Rouen University Hospital

Rouen, 76000, France

Location

Leeds Teaching Hospital NHS Foundation Trust

Leeds, Yorkshire, LS2 9LN, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36342884DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nick Hart

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 21, 2015

Study Start

March 1, 2015

Primary Completion

June 30, 2018

Study Completion

October 30, 2018

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data

Locations

GB(4)FR(2)