Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT00990132
Eligibility Criteria:
Inclusion Criteria:
* Patients with COPD
* Acute hypercapnic exacerbation of COPD at least 2 weeks previously
* Tolerated non-invasive ventilation during acute hypercapnic exacerbation
* Chronic hypoxia requiring LTOT (PaO2 \<7.3kPa or a PaO2 \>7.3 and \<8.0kPa and one of the following: secondary polycythaemia; nocturnal hypoxaemia SaO2 \<90% for \>30% of the time; peripheral oedema; or PHT)
* Chronic hypercapnia (PaCO2 \>7kPa)
* ≥20 pack year smoking history
* FEV1/FVC \<60%
* FEV1 at \<50% predicted
Exclusion Criteria:
* Persistent hypercapnic respiratory failure with acidosis (defined as pH \<7.30 after bronchodilators)
* Development of worsening hypercapnic respiratory failure with acidosis during initiation of LTOT therapy
* Failure to tolerate NIV during the acute illness preceding trial identification
* Post extubation or decannulation following AHRF requiring intubation
* Restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the FEV1/FVC ratio is \<60% and the FEV1 \<50% if the predominant defect is considered to be obstructive by the center clinician.
* Clinical features of severe OSA
* BMI \>35kg/m2
* Unstable coronary artery syndrome
* Cognitive impairment that would prevent informed consent into the trial
* Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
* Patients undergoing renal replacement therapy
* Age \<18 years
* Pregnant
* Inability to comply with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00990132
Study Brief:
Protocol Section:
NCT00990132