High-Intensity vs Low-Intensity NPPV in Patients With an AECOPD: The HAPPEN Trial
- Conditions
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Interventions
- Device: High-intensity NPPVDevice: Low-intensity NPPV
- Registration Number
- NCT02985918
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-intensity NPPV High-intensity NPPV Patients will receive high-intensity NPPV. Low-intensity NPPV Low-intensity NPPV Patients will receive low-intensity NPPV.
- Primary Outcome Measures
Name Time Method The need for endotracheal intubation during hospitalization From randomization to discharge from hospital Defined as the proportion of patients who needed for endotracheal intubation during hospitalization after randomization
- Secondary Outcome Measures
Name Time Method Live discharge from the hospital From randomization to discharge from hospital Defined as the proportion of patients with the exception of those who died and withdrawn treatment therapy during hospitalization after randomization.
Actual intubation during hospitalization From randomization to discharge from hospital Defined as the proportion of patients actually receiving intubation and invasive ventilation during hospitalization after randomization
The composite of actual intubation or avoiding intubation by crossover to high-intensity NPPV From randomization to discharge from hospital 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
Mortality at day 28 Within 28 days since randomization Intensive care unit admission From randomization to discharge from hospital Defined as the proportion of patients who transferred to ICU during hospitalization after randomization
Hospital readmission at day 90 Within 90 days since randomization Defined as the number of hospitalization days within 90 days since randomization
Length of hospital stay after randomization From randomization to discharge from hospital Defined as the number of hospitalization days since randomization
Invasive ventilator-free days at day 28 Within 28 days since randomization Defined as 28 minus the number of days with invasive ventilator (range, 0-28 days) since randomization
Need for endotracheal intubation at day 28 Within 28 days since randomization Defined as the proportion of patients who needed endotracheal intubation within 28 days since randomization
NPPV weaning success From randomization to discharge from hospital 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
Mortality in hospital From randomization to discharge from hospital Mortality at day 90 Within 90 days since randomization Length of hospital stay From hospital admission to discharge Defined as the number of days for the index hospitalization
ICU-free days at day 28 Within 28 days since randomization Defined as 28 minus the number of days in the ICU (range, 0-28 days) since randomization
Actual intubation at day 28 Within 28 days since randomization Defined as the proportion of patients receiving intubation and invasive ventilation within 28 days after randomization
Trial Locations
- Locations (31)
Wuyuan Hospital of Inner Mongolia
🇨🇳Bayan Nur, China
The First Affiliated Hospital of Hanan University,
🇨🇳Kaifeng, 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
Dalian Friendship Hospital
🇨🇳Dalian, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Shulan (Hang Zhou) Hospital
🇨🇳Hangzhou, China
Hemei General Hospital
🇨🇳Hebi, China
Huangshi Central Hospital
🇨🇳Huangshi, China
Dalian Municipal Central Hospital
🇨🇳Dalian, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Kaifeng Central Hospital
🇨🇳Kaifeng, China
Jiaozuo People's Hospital
🇨🇳Jiaozuo, China
The First People's Hospital of Luoyang
🇨🇳Luoyang, China
Jiaozuo Second Hospital
🇨🇳Jiaozuo, China
Nanyang First People's Hospital
🇨🇳Nanyang, China
Nanyang Central Hospital
🇨🇳Nanyang, China
The Third Hospital of Mianyang
🇨🇳Mianyang, China
Sanmenxia Central Hospital
🇨🇳Sanmenxia, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, China
The Second Hospital of Tongliao
🇨🇳Tongliao, China
Xinxiang Central Hospital
🇨🇳Xinxiang, China
Zhengzhou Central Hospital
🇨🇳Zhengzhou, China
Hunan Province Directly Affiliated TCM Hospital
🇨🇳Zhuzhou, China
Zibo First Hospital
🇨🇳Zibo, China