Loading clinical trials...

High-Intensity vs Low-Intensity NPPV in Patients With an AECOPD: The HAPPEN Trial | Clinical Trials | Clareo Health

TERMINATEDNA

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

Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease The HAPPEN Randomized Clinical Trial

NCT02985918•Beijing Chao Yang Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+7 more criteria

Locations (31)

Wuyuan Hospital of Inner Mongolia

Bayan Nur, China

Beijing Chao-Yang Hospital

Beijing, China

Beijing Fangshan Liangxiang Hospital,

Beijing, China

Beijing Jingmei Group General Hospital

Beijing, China

Beijing Luhe Hospital

Beijing, China

Beijing Mentougou District Hospital

Beijing, China

Beijing Pinggu Hospital

Beijing, China

Beijing Zhongguancun Hospital

Beijing, China

Capital Medical University Daxing Teaching Hospital

Beijing, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Key Dates

Start Date

January 3, 2019

Primary Completion Date

January 31, 2022

Completion Date

April 22, 2022

Last Updated

February 7, 2024

Enrollment

300

ACTUAL participants

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

High-intensity NPPV

DEVICE

Low-intensity NPPV

DEVICE

Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT06175065

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions