Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02342899
Study type Interventional
Source Guy's and St Thomas' NHS Foundation Trust
Contact
Status Completed
Phase Phase 3
Start date March 1, 2015
Completion date October 30, 2018

See also
  Status Clinical Trial Phase
Completed NCT01903135 - Prevalence of Obesity Hypoventilation Syndrome N/A
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Withdrawn NCT03861468 - Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS ) N/A
Completed NCT01368614 - AVAPS-AE Efficacy Study N/A
Terminated NCT01964339 - Obesity Hypoventilation Syndrome Prevalence Study
Completed NCT04108819 - Ketogenic Diet for Obesity Hypoventilation Syndrome N/A
Completed NCT02934581 - Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units
Terminated NCT03353064 - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure N/A
Completed NCT03085537 - Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform
Recruiting NCT02980770 - Postoperative Complications in Patients With Obesity Hypoventilation Syndrome N/A
Completed NCT01483716 - A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS) N/A
Completed NCT01499485 - Treatment of Metabolic Alkalosis With Acetazolamide. Effect on the Length of Mechanical Ventilation. Phase 3
Completed NCT03506906 - The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation N/A
Terminated NCT02317042 - Juno Perth Clinical Trial N/A
Completed NCT01405976 - Alternative of Treatment in Obesity Hypoventilation Syndrome N/A
Withdrawn NCT01104610 - Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome N/A
Recruiting NCT03854058 - Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease
Not yet recruiting NCT05190458 - Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome N/A
Recruiting NCT04100616 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity
Completed NCT01757444 - Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS N/A