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

Beijing Chao Yang Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

High-intensity NPPVDEVICE

In the high-intensity NPPV group, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O, typically ranging from 20 to 30 cmH2O (or a tolerated maximum), to obtain a VT 10-15 mL/kg PBW and a respiratory rate \<25 breaths/min. Subsequent adjustments to IPAP are based on the results of arterial blood gases (ABGs; up to 30 cmH2O) to achieve normocapnia (if possible), or to maximally decrease PaCO2 toward normocapnia if normocapnia can not be achieved. If PaCO2 decreases to less than 35 mmHg, IPAP will be decreased to achieve normocapnia.

Low-intensity NPPVDEVICE

In the low-intensity NPPV group, as well as during the 6-hour trial of low-intensity NPPV, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT 6-10 mL/kg PBW and a respiratory rate \<25 breaths/min. Subsequent adjustments to IPAP are based on the results of ABGs (up to 20 cmH2O) to achieve a pH of ≥7.35 and to reduce PaCO2 to a level deemed appropriate by the attending physician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

The need for endotracheal intubation during hospitalization

Defined as the proportion of patients who needed for endotracheal intubation during hospitalization after randomization

Time frame: From randomization to discharge from hospital

Secondary Outcomes

Actual intubation during hospitalization

Defined as the proportion of patients actually receiving intubation and invasive ventilation during hospitalization after randomization

Time frame: From randomization to discharge from hospital

Need for endotracheal intubation at day 28

Defined as the proportion of patients who needed endotracheal intubation within 28 days since randomization

Time frame: Within 28 days since randomization

Actual intubation at day 28

Defined as the proportion of patients receiving intubation and invasive ventilation within 28 days after randomization

Time frame: Within 28 days since randomization

The composite of actual intubation or avoiding intubation by crossover to high-intensity NPPV

Defined as the incidence of patients receiving actual intubation in the high-intensity NPPV group vs the composite incidence of actual intubation or avoiding intubation by crossover to high-intensity NPPV in case of intubation criteria in the low-intensity NPPV group) during hospitalization after randomization

Time frame: From randomization to discharge from hospital

NPPV weaning success

Defined as the proportion of patients with persistent disconnection of NPPV without the presence of respiratory distress within the following 72 hours during hospitalization after randomization

Data from ClinicalTrials.gov

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