Factors Associated With Chronic Respiratory Failure in Obesity

• ClinicalTrials.gov Identifier: NCT01380418
• Recruitment Status: Completed
• First Posted: June 27, 2011
• Last Update Posted: September 12, 2017
• Sponsor: Oxford University Hospitals NHS Trust
• Information provided by (Responsible Party): Ari Manuel, Oxford University Hospitals NHS Trust

Tracking Information

• First Submitted Date: June 16, 2011
• First Posted Date: June 27, 2011
• Last Update Posted Date: September 12, 2017
• Study Start Date: June 2011
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 24, 2011)

To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ]

This will be a detailed ventilatory drive measurements and muscle strength testing. The comparison will be made within the group amongst the range of ventilatory failure

Original Primary Outcome Measures (submitted: June 22, 2011)

To determine the physiological between obese patients with OHS and obese patients without OHS [ Time Frame: 1 year ]

This will be a detailed sleep study, lung function testing, ventilatory drive measurements and muscle strength testing. The comparison will be made within the group amongst the range of ventilatory failure

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Factors Associated With Chronic Respiratory Failure in Obesity
• Official Title: Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study

Brief Summary

Some overweight individuals develop problems with their breathing such that they gradually breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the blood, called ventilatory failure. As a consequence, if such a person develops a chest infection, they are more likely to become seriously ill and need intensive care. In addition they are much more likely to develop severe complications during and following operations. This problem can be treated with a machine at home used overnight to help breathing. It is interesting that ventilatory failure only happens in some overweight individuals, and the investigators do not understand what factors make this complication develop. There are a number of theories: for example the distribution of the fat, additional lung disease (such as asthma), the addition of obstructive sleep apnoea, a condition when there are periods of cessation of breathing overnight (which is more common in obese individuals), weak muscles of breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other hormonal changes.

The investigators intend to measure many potential factors in a range of overweight individuals, some who have ventilatory failure, and some who do not, to try and work out which are the important factors that cause this problem. If the investigators can identify such factors, then this will help predict in advance who is at risk from chest infections and during operations; thus allowing for earlier provision of an overnight breathing machine. This should reduce complications and potentially deaths in such individuals.

• Detailed Description: To test the hypothesis that in obese patients with obesity-hypoventilation (OHS) there are specific factors related to the development of ventilatory failure, compared to obese subjects not in ventilatory failure
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood, fat, muscle

• Sampling Method: Non-Probability Sample

Study Population

Obese (BMI > 30kg/m2) with or without OHS (18-85yrs)

1. Admitted for management of OHS
2. Attending the sleep and ventilation clinic
3. Being assessed for bariatric surgery

Condition

• Obesity
• Obesity Hypoventilation Syndrome

• Intervention: Not Provided

Study Groups/Cohorts

Study group

Obese BMI>30 18-85 years old

Publications *

• Dattani RS, Swerner CB, Stradling JR, Manuel AR. Exploratory study into the effect of abdominal mass loading on airways resistance and ventilatory failure. BMJ Open Respir Res. 2016 Jun 9;3(1):e000138. doi: 10.1136/bmjresp-2016-000138. eCollection 2016.
• Manuel AR, Hart N, Stradling JR. Correlates of obesity-related chronic ventilatory failure. BMJ Open Respir Res. 2016 Feb 18;3(1):e000110. doi: 10.1136/bmjresp-2015-000110. eCollection 2016.
• Manuel ARG, Hart N, Stradling JR. Is a raised bicarbonate, without hypercapnia, part of the physiologic spectrum of obesity-related hypoventilation? Chest. 2015 Feb;147(2):362-368. doi: 10.1378/chest.14-1279.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 8, 2017): 78
• Original Estimated Enrollment (submitted: June 22, 2011): 60
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Obese (BMI > 30) with or without obesity hypoventilation
• (OHS) (18 - 85yrs)
• Admitted for management of their OHS
• Attending the sleep and ventilation clinic
• Being assessed for bariatric surgery
• Willing and able to give informed consent for participation in the study
• Men and women aged 18 - 85 years

Exclusion Criteria:

• Respiratory acidosis pH <7.30
• Severe untreated hypothyroidism
• Current treatment with theophylline
• Current treatment with diuretics
• Severe restrictive or obstructive lung disease (<30% predicted)
• Severe comorbidities such as moderate/severe COPD, left sided heart failure, and primary CNS or neuromuscular diseases
• Contraindications to MRI scanning
• Contraindications to DXA scanning
• Previous participant in research in the last 12 months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01380418
• Other Study ID Numbers: 11/H0605/9
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ari Manuel, Oxford University Hospitals NHS Trust
• Original Responsible Party: Heather House, Oxford Radcliffe Hospitals NHS Trust
• Current Study Sponsor: Oxford University Hospitals NHS Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: John Stradling, FRCP MBBS PHD; University of Oxford

• PRS Account: Oxford University Hospitals NHS Trust
• Verification Date: September 2017