High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: the HAPPEN Study (HAPPEN)

Study Overview
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Brief Summary
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The main purpose of the present study is to verify whether, as compared with conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive positive pressure ventilation may more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with acute exacerbation of chronic obstructive pulmonary disease.

Official Title
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High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Controlled Trial

Conditions
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Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: High-intensity NPPV
* Device: Conventional-intensity NPPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2016 Presence of acute exacerbation Arterial pH <7.35 with arterial carbon dioxide tension >45 mmHg 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 Severe abdominal distension Active upper gastrointestinal bleeding Cardiac or respiratory arrest; Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) <150 mmHg Pneumothorax Severe ventricular arrhythmia or myocardial ischemia Severe hemodynamic instability despite fluid repletion and use of vasoactive agents Severe metabolic acidosis Refusal to receive NPPV Lack of cooperation Intolerance of NPPV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity NPPV<br>The patients will receive high-intensity noninvasive positive pressure ventilation. | Device: High-intensity NPPV<br>* The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 30 cmH2O), to obtain a VT of 15 mL/kg of predicted body weight, and to achieve normocapnia as possible as it can.<br>|
| Active Comparator: Conventional-intensity NPPV<br>The patients will receive conventional-intensity noninvasive positive pressure ventilation. | Device: Conventional-intensity NPPV<br>* The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 20 cmH2O), to obtain a VT of 10 mL/kg of predicted body weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrements of PaCO2 measured at 2 hours after enrollment. |  | 2 hours | 
| The decrements of PaCO2 measured at 6 hours after enrollment. |  | 6 hours | 
| The decrements of PaCO2 measured at 24 hours after enrollment. |  | 24 hours | 
| The decrements of PaCO2 measured at 48 hours after enrollment. |  | 48 hours | 
| ICU mortality rate |  | 1 year | 
| 28-day mortality rate |  | 28 days | 
| Hospital survival rate |  | 1 year | 
| 90-day mortality rate |  | 90 days | 
| ICU length of stay |  | 1 year | 
| Hospital length of stay |  | 1 year | 
| Complication related to NPPV |  | 1 year |