High-Intensity vs Low-Intensity NPPV in Patients With an AECOPD: The HAPPEN Trial

Capital Medical University

Status

Terminated

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatments

Device: High-intensity NPPV

Device: Low-intensity NPPV

Study type

Interventional

Funder types

Other

Identifiers

NCT02985918

BeijingCYH-ICU-004

Details and patient eligibility

About

To determine whether high-intensity NPPV, compared with low-intensity NPPV, could reduce the need for endotracheal intubation during hospitalization in patients with an AECOPD and hypercapnia.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Arterial pH <7.35 and PaCO2 >45 mmHg at screening entry
PaCO2 >45 mmHg after a 6-hour trial of low-intensity NPPV

Exclusion criteria

Age <18 years
Excessive respiratory secretions with weak cough
Upper airway obstruction
Recent oral, facial, or cranial trauma or surgery
Recent gastric or esophageal surgery
Presence of 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, or severe abdominal distension)
Active upper gastrointestinal bleeding
Cardiac or respiratory arrest
Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) <100 mmHg
Pneumothorax
Obvious emphysematous bullae confirmed by chest CT scan
Ventricular arrhythmia or myocardial ischemia
Severe hemodynamic instability (mean arterial pressure <65 mmHg)
Severe metabolic acidosis (pH <7.20 and bicarbonate <22 mmol/L)
Refusal to receive NPPV or give informed consent
Prior endotracheal intubation or tracheostomy during the current hospitalization
A do-not-intubate order