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Home oxygen therapy versus home mechanical ventilation for chronic obstructive pulmonary disease

Not Applicable
Completed
Conditions
Topic: Respiratory
Subtopic: Respiratory (all Subtopics)
Disease: Respiratory
Respiratory
Registration Number
ISRCTN28058693
Lead Sponsor
Guy's and St. Thomas' NHS Foundation Trust (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
116
Inclusion Criteria

1. Acute hypercapnic exacerbation of COPD at least 2 weeks previously
2. In patient admission with acute hypercapnic respiratory failure
3. Smoking greater than 20 pack year history
4. Forced expiratory volume in one second (FEV1) less than 50%
5. FEV1/forced vital capacity (FVC) less than 60%
6. Chronic hypercapnia (PaCO2 greater than 7 kPa)
7. Chronic hypoxia PaO2 less than 7.3 kPa or less than 8 kPa with secondary polycythaemia, pulmonary hypertension, peripheral oedema or significant nocturnal hypoxia (SpO2 less than 90% for greater than 30% sleep time)
8. Aged 18 years or older, either sex

Exclusion Criteria

1. Unable to wean off NIV prior to discharge (persistent hypercapnic respiratory failure with pH less than 7.30)
2. Post extubation or decanulation
3. Body mass index (BMI) greater than 35 kg/m^2
4. Primary diagnosis of restrictive lung disease causing hypercapnia
5. Development of worsening hypercapnic respiratory failure with acidosis during initiation of oxygen therapy (ABG - pH less than 7.30 taken 2 - 4 hours after waking)
6. Unable to tolerate NIV (if given) during acute illness
7. Unstable coronary artery syndrome
8. Renal replacement therapy
9. Inability to consent/comply with trial protocol (as determined by site PI)
10. Aged less than 18 years
11. Pregnant

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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