RecruitingACTRN12608000172303

Effect of supplemental oxygen in patients with chronic hypercapnic respiratory failure

Ventilatory and haemodynamic responses to supplemental oxygen in patients with chronic hypercapnic respiratory failure

Sponsor

Royal Prince Alfred Hospital

Enrollment

28 participants

Start Date

Apr 21, 2008

Study Type

Interventional

Conditions

Chronic hypercapnic respiratory failure due to obesity hypoventilation syndrome

Summary

In medical practice and published research, it is well documented that in some patients with respiratory failure due to chronic lung disease, breathing high concentrations of oxygen can cause carbon dioxide levels to increase, sometimes to potentially harmful levels. The effect of oxygen on patients who have chronic respiratory failure from other causes such as obesity hypoventilation syndrome is less clear. We would like to test the effect of two concentrations of oxygen on breathing pattern and carbon dioxide levels in patients who have chronic respiratory failure due to obesity hypoventilation syndrome. We expect that breathing high concentration oxygen will cause an increase in carbon dioxide levels and alter breathing pattern in this group. It has also been proposed that this group, treating (and reversing) hypercapnia through the use of nocturnal positive airway pressure therapy may improve responsiveness to carbon dioxide, thereby minimising the potentially harmful effects of supplemental oxygen. We hypothesised that three months of treatment with nocturnal positive airway pressure would lessen any adverse responses to supplemental oxygen observed during testing at initial presentation.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is examining how breathing different concentrations of oxygen affects breathing patterns and carbon dioxide levels in people who have chronic (long-term) respiratory failure due to obesity-related breathing problems (obesity hypoventilation syndrome) or neuromuscular diseases. It also looks at whether treatment with nighttime breathing support (positive airway pressure therapy) can reduce harmful effects from oxygen. You may be eligible if: - You are between 18 and 90 years old - You have been diagnosed with chronic respiratory failure caused by obesity hypoventilation syndrome or a neuromuscular disease You may NOT be eligible if: - You are experiencing acute (sudden, severe) respiratory failure or a recent respiratory illness - You have obstructive lung disease (such as COPD) - You are pregnant - You have an unstable heart condition - You have a psychiatric illness - You do not speak English Talk to your doctor about whether this trial might be right for you.

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Interventions

During a testing session, participants will breathe supplemental oxygen at 2 concentrations (fraction of inspired oxygen 28% and 50%) for 20 minutes each. There will be a one-hour washout period between interventions. A group of healthy control participants will be tested on only one occasion to allow us to document the normal response to 28% and 50% oxygen. Participants with hypercapnic respiratory failure will perform testing on two occasions: once at initial presentation with untreated hypercapnic respiratory failure; and once after three months of treatment with nocturnal positive airway pressure therapy. Nocturnal positive airway pressure will be prescribed and implemented in accordance with usual clinical practice at our centre. Some data collected as part of this study will also be used for two measurement validation studies. The first study is investigating the validity of arterialised venous blood gases against gold standard acid-base measures obtained from arterial blood gases. A single pair of simultaneously taken arterialised venous and arterial blood samples taken during each testing session will used for this validation. The second study is investigating the validity of respiratory inductive plethysmography in people with obesity hypoventilation syndrome and healthy controls. Simultaneous repeated measurements of tidal volume, minute ventilation, and respiratory rate measured by the air/oxygen breathing circuit and a non-invasive respiratory inductance vest will be compared for this validation study.

Locations(1)

Australia

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ACTRN12608000172303