Factors Associated With Chronic Respiratory Failure in Obesity

Obesity Clinical Trial

Official title:

Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380418
• Other study ID #: 11/H0605/9
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: September 8, 2017
• Start date: June 2011
• Est. completion date: October 2015

Study information

• Verified date: September 2017
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Other known NCT identifiers

• NCT01385462

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Respiratory Insufficiency

Locations

Country	Name	City	State
United Kingdom	Oxford Radcliffe NHS Trust Hospitals	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the physiological between obese patients with OHS and obese patients without OHS	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	1 year