High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: the HAPPEN Study (HAPPEN)

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02985918

Collaborator

(none)

300

Enrollment

Locations

Arms

39.7

Actual Duration (Months)

11.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the present study is to verify whether, as compared with conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive positive pressure ventilation may more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with acute exacerbation of chronic obstructive pulmonary disease.

Condition or Disease	Intervention/Treatment	Phase
Acute Exacerbation of Chronic Obstructive Pulmonary Disease	Device: High-intensity NPPV Device: Conventional-intensity NPPV	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Controlled Trial

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Apr 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-intensity NPPV The patients will receive high-intensity noninvasive positive pressure ventilation.	Device: High-intensity NPPV The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 30 cmH2O), to obtain a VT of 15 mL/kg of predicted body weight, and to achieve normocapnia as possible as it can.
Active Comparator: Conventional-intensity NPPV The patients will receive conventional-intensity noninvasive positive pressure ventilation.	Device: Conventional-intensity NPPV The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 20 cmH2O), to obtain a VT of 10 mL/kg of predicted body weight.

Arm

Intervention/Treatment

Experimental: High-intensity NPPV

The patients will receive high-intensity noninvasive positive pressure ventilation.

Device: High-intensity NPPV

The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 30 cmH2O), to obtain a VT of 15 mL/kg of predicted body weight, and to achieve normocapnia as possible as it can.

Active Comparator: Conventional-intensity NPPV

The patients will receive conventional-intensity noninvasive positive pressure ventilation.

Device: Conventional-intensity NPPV

The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 20 cmH2O), to obtain a VT of 10 mL/kg of predicted body weight.

Outcome Measures

Primary Outcome Measures

Intubation rate [1 year]

Secondary Outcome Measures

The decrements of PaCO2 measured at 2 hours after enrollment. [2 hours]
The decrements of PaCO2 measured at 6 hours after enrollment. [6 hours]
The decrements of PaCO2 measured at 24 hours after enrollment. [24 hours]
The decrements of PaCO2 measured at 48 hours after enrollment. [48 hours]
ICU mortality rate [1 year]
28-day mortality rate [28 days]
Hospital survival rate [1 year]
90-day mortality rate [90 days]
ICU length of stay [1 year]
Hospital length of stay [1 year]
Complication related to NPPV [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2016
Presence of acute exacerbation
Arterial pH <7.35 with arterial carbon dioxide tension >45 mmHg

Exclusion Criteria:

age <18 years
Excessive amount of respiratory secretions or weak cough
Upper airway obstruction
Recent oral, facial, or cranial trauma or surgery
Recent gastric or esophageal surgery
Severe abdominal distension
Active upper gastrointestinal bleeding
Cardiac or respiratory arrest;
Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) <150 mmHg
Pneumothorax
Severe ventricular arrhythmia or myocardial ischemia
Severe hemodynamic instability despite fluid repletion and use of vasoactive agents
Severe metabolic acidosis
Refusal to receive NPPV
Lack of cooperation
Intolerance of NPPV

Contacts and Locations

Locations

	Site	City	Country
1	The Second Hospital of Baoji	Baoji	China
2	The Third Hospital of Baoji	Baoji	China
3	Beijing Chao-Yang Hospital	Beijing	China
4	Beijing Mentougou District Hospital	Beijing	China
5	Beijing Pinggu Hospital	Beijing	China
6	Beijing Renhe Hospital	Beijing	China
7	People's Hospital of Beijing Huairou District	Beijing	China
8	Chongqing Xin-Qiao Hospital	Chongqing	China
9	Gongyi City People's Hospital	Gongyi	China
10	Haicheng Central Hospital	Haicheng	China
11	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	China
12	People's Hospital of Hanshou	Hanshou	China
13	The First Hospital of University of South China	Hengyang	China
14	The Second Hospital of University of South China	Hengyang	China
15	The Affiliated Hospital of Henan Polytechnic University	Jiaozuo	China
16	Kaifeng Central Hospital	Kaifeng	China
17	The First Affiliated Hospital of Henan University	Kaifeng	China
18	The Affiliated Hospital of Kunming University of Science and Technology	Kunming	China
19	The Third Hospital of Mianyang	Mianyang	China
20	National Hospital of Guangxi Zhuang Autonomous Region	Nanning	China
21	Nanyang Central Hospital	Nanyang	China
22	Sanmenxia Central Hospital	Sanmenxia	China
23	The Affiliated Hospital of North China University of Science of Technology	Tangshan	China
24	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	China
25	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	China
26	The First Affiliated Hospital of Xi'an Medical University	Xian	China
27	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	China

Sponsors and Collaborators

Beijing Chao Yang Hospital

Investigators

Principal Investigator: Zujin Luo, MD, Beijing Chao Yang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zujin Luo, Principal Investigator, Beijing Chao Yang Hospital

ClinicalTrials.gov Identifier:

NCT02985918

Other Study ID Numbers:

BeijingCYH-ICU-004

First Posted:

Dec 7, 2016

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of May 17, 2022