Clinical trial NCT02985918: High-Intensity vs Low-Intensity NPPV in Patients With an AECOPD: The HAPPEN Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The need for endotracheal intubation during hospitalization
timeFrame: From randomization to discharge from hospital
Secondary outcomes:
measure: Actual intubation during hospitalization
timeFrame: From randomization to discharge from hospital
measure: Need for endotracheal intubation at day 28
timeFrame: Within 28 days since randomization
measure: Actual intubation at day 28
timeFrame: Within 28 days since randomization
measure: The composite of actual intubation or avoiding intubation by crossover to high-intensity NPPV
timeFrame: From randomization to discharge from hospital
measure: NPPV weaning success
timeFrame: From randomization to discharge from hospital
measure: Mortality in hospital
timeFrame: From randomization to discharge from hospital
measure: Mortality at day 28
timeFrame: Within 28 days since randomization
measure: Mortality at day 90
timeFrame: Within 90 days since randomization
measure: Intensive care unit admission
timeFrame: From randomization to discharge from hospital
measure: Live discharge from the hospital
timeFrame: From randomization to discharge from hospital
measure: Length of hospital stay
timeFrame: From hospital admission to discharge
measure: Length of hospital stay after randomization
timeFrame: From randomization to discharge from hospital
measure: Invasive ventilator-free days at day 28
timeFrame: Within 28 days since randomization
measure: ICU-free days at day 28
timeFrame: Within 28 days since randomization
measure: Hospital readmission at day 90
timeFrame: Within 90 days since randomization
Other outcomes:
Locations:
city: Bayan Nur
country: China
facility: Wuyuan Hospital of Inner Mongolia
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Beijing Fangshan Liangxiang Hospital,
city: Beijing
country: China
facility: Beijing Jingmei Group General Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital
city: Beijing
country: China
facility: Beijing Mentougou District Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Beijing
country: China
facility: Beijing Zhongguancun Hospital
city: Beijing
country: China
facility: Capital Medical University Daxing Teaching Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: Dalian Friendship Hospital
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
city: Hangzhou
country: China
facility: Shulan (Hang Zhou) Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
city: Hebi
country: China
facility: Hemei General Hospital
city: Huangshi
country: China
facility: Huangshi Central Hospital
city: Jiaozuo
country: China
facility: Jiaozuo People's Hospital
city: Jiaozuo
country: China
facility: Jiaozuo Second Hospital
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
city: Kaifeng
country: China
facility: The First Affiliated Hospital of Hanan University,
city: Luoyang
country: China
facility: The First People's Hospital of Luoyang
city: Mianyang
country: China
facility: The Third Hospital of Mianyang
city: Nanyang
country: China
facility: Nanyang Central Hospital
city: Nanyang
country: China
facility: Nanyang First People's Hospital
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
city: Tongliao
country: China
facility: The Second Hospital of Tongliao
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
city: Zhuzhou
country: China
facility: Hunan Province Directly Affiliated TCM Hospital
city: Zibo
country: China
facility: Zibo First Hospital
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zujin Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo Z, Wu C, Li Q, Zhu J, Pang B, Shi Y, Ma Y, Cao Z; HAPPEN collaboration group. High-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease (HAPPEN): study protocol for a multicenter randomized controlled trial. Trials. 2018 Nov 21;19(1):645. doi: 10.1186/s13063-018-2991-y.