NCT04044625
Completed
Not Applicable
Effects of High-intensity Versus Low-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Beijing Chao Yang Hospital1 site in 1 country24 target enrollmentSeptember 30, 2019
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Sponsor
- Beijing Chao Yang Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- PaCO2 measured at 24 hours after enrollment
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (NPPV), as compared with low-intensity NPPV, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, NPPV tolerance, inflammatory response, adverse events and other outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease.
Investigators
Zujin Luo
Principal Investigator
Beijing Chao Yang Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019
- •Presence of acute exacerbation
- •Arterial pH \<7.35 with arterial carbon dioxide tension (PaCO2) \>45 mmHg on room air or supplemental oxygen
- •PaCO2 \>45 mmHg following low-intensity NPPV of ≥6 hours
Exclusion Criteria
- •Age \<18 years
- •Excessive amount of respiratory secretions or weak cough
- •Upper airway obstruction
- •Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery
- •Potential risk factors for restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, and severe abdominal distention)
- •Active upper gastrointestinal bleeding
- •Cardiac or respiratory arrest
- •Arterial oxygen tension/fraction of inspired oxygen \<100 mmHg
- •Pneumothorax
- •Severe ventricular arrhythmia or myocardial ischemia
Outcomes
Primary Outcomes
PaCO2 measured at 24 hours after enrollment
Time Frame: 24 hours
PaCO2 measured at 24 hours after enrollment.
Secondary Outcomes
- PaCO2 measured at 2 hours after enrollment(2 hours)
- PaCO2 measured at 6 hours after enrollment(6 hours)
- PaCO2 measured at 48 hours after enrollment(48 hours)
- PaCO2 measured at 72 hours after enrollment(72 hours)
- Glasgow coma scale score(72 hours)
- ΔPes(72 hours)
- Dyspnea score(72 hours)
- NPPV tolerance score(72 hours)
- Plasma level of TNF-α(72 hours)
- Plasma level of I-1β(72 hours)
- Plasma level of IL-6(72 hours)
- Plasma level of IL-8(72 hours)
- Plasma level of IL-10(72 hours)
Study Sites (1)
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