ISRCTN64639614
Active, not recruiting
未知
Standard versus accelerated weaning from non-invasive ventilation (NIV) in chronic obstructive pulmonary disease directed by the NIV outcomes score: a randomised controlled trial
orthumbria Healthcare NHS Foundation Trust0 sites164 target enrollmentSeptember 14, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orthumbria Healthcare NHS Foundation Trust
- Enrollment
- 164
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Clinical diagnosis of Exacerbation of Chronic Obstructive Pulmonary Disease, complicated by acute hypercapnic respiratory failure (pH \<7\.35 and PaCO2 \>6\.5 kPa)
- •2\. Age 35 years or over
- •3\. Smoking history of 10 or more pack years
- •4\. Low or medium risk Non\-Invasive Ventilation (NIV) Outcomes score
- •5\. Provision of acute NIV for 24 hours or longer
- •6\. Correction of respiratory acidaemia
- •7\. PaCO2 \<8 kPa, or PaCO2 8\-9 kPa with at least a 20% fall in PaCO2 from pre\-NIV baseline value
- •8\. Able to tolerate 60 minutes of unsupported breathing, confirmed by arterial blood gas (ABG)
- •9\. Participants must be randomised within 24 hours of meeting the weaning criteria (based on the time of the qualifying ABG)
Exclusion Criteria
- •1\. Poor tolerance of NIV likely to limit adherence to protocol
- •2\. Receiving home ventilation on admission, or planned referral for home ventilation on discharge
- •3\. Inability to provide informed consent
- •4\. Failure of another organ requiring level 2 or 3 organ support
- •5\. Clinically significant pulmonary fibrosis
- •6\. Metastatic cancer, advanced haematological malignancy, or other serious comorbidities, which may influence survival or decisions about ventilation within the time frame of the trial (3 months)
Outcomes
Primary Outcomes
Not specified
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