Clinical trial NCT04044625: Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD
Official title: Effects of High-intensity Versus Low-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019
2. Presence of acute exacerbation
3. Arterial pH \<7.35 with arterial carbon dioxide tension (PaCO2) \>45 mmHg on room air or supplemental oxygen
4. PaCO2 \>45 mmHg following low-intensity NPPV of ≥6 hours

Exclusion Criteria:

1. Age \<18 years
2. Excessive amount of respiratory secretions or weak cough
3. Upper airway obstruction
4. Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery
5. 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)
6. Active upper gastrointestinal bleeding
7. Cardiac or respiratory arrest
8. Arterial oxygen tension/fraction of inspired oxygen \<100 mmHg
9. Pneumothorax
10. Severe ventricular arrhythmia or myocardial ischemia
11. Severe hemodynamic instability despite fluid repletion and use of vasoactive agents
12. Severe metabolic acidosis
13. Refusal to receive NPPV
14. Endotracheal intubation already performed before ICU admission

Primary outcomes:
measure: PaCO2 measured at 24 hours after enrollment
timeFrame: 24 hours
Secondary outcomes:
measure: PaCO2 measured at 2 hours after enrollment
timeFrame: 2 hours
measure: PaCO2 measured at 6 hours after enrollment
timeFrame: 6 hours
measure: PaCO2 measured at 48 hours after enrollment
timeFrame: 48 hours
measure: PaCO2 measured at 72 hours after enrollment
timeFrame: 72 hours
measure: Glasgow coma scale score
timeFrame: 72 hours
measure: ΔPes
timeFrame: 72 hours
measure: Dyspnea score
timeFrame: 72 hours
measure: NPPV tolerance score
timeFrame: 72 hours
measure: Plasma level of TNF-α
timeFrame: 72 hours
measure: Plasma level of I-1β
timeFrame: 72 hours
measure: Plasma level of IL-6
timeFrame: 72 hours
measure: Plasma level of IL-8
timeFrame: 72 hours
measure: Plasma level of IL-10
timeFrame: 72 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zujin Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo Z, Cao Z, Li Y, Jin J, Sun W, Zhu J, Zhao N, Liu J, Wei B, Hu Y, Zhang Y, Ma Y, Wang C. Physiological effects of high-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomised controlled trial. Ann Intensive Care. 2022 May 19;12(1):41. doi: 10.1186/s13613-022-01018-4.