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

Primary Purpose

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-intensity NPPV
Conventional-intensity NPPV
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Second Hospital of Baoji
  • The Third Hospital of Baoji
  • Beijing Chao-Yang Hospital
  • Beijing Mentougou District Hospital
  • Beijing Pinggu Hospital
  • Beijing Renhe Hospital
  • People's Hospital of Beijing Huairou District
  • Chongqing Xin-Qiao Hospital
  • Gongyi City People's Hospital
  • Haicheng Central Hospital
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • People's Hospital of Hanshou
  • The First Hospital of University of South China
  • The Second Hospital of University of South China
  • The Affiliated Hospital of Henan Polytechnic University
  • Kaifeng Central Hospital
  • The First Affiliated Hospital of Henan University
  • The Affiliated Hospital of Kunming University of Science and Technology
  • The Third Hospital of Mianyang
  • National Hospital of Guangxi Zhuang Autonomous Region
  • Nanyang Central Hospital
  • Sanmenxia Central Hospital
  • The Affiliated Hospital of North China University of Science of Technology
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The First Affiliated Hospital of Xi'an Medical University
  • The Second Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity NPPV

Conventional-intensity NPPV

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intubation rate

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2016
Last Updated
May 14, 2022
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02985918
Brief Title
High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: the HAPPEN Study (HAPPEN)
Official Title
High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity NPPV
Arm Type
Experimental
Arm Description
The patients will receive high-intensity noninvasive positive pressure ventilation.
Arm Title
Conventional-intensity NPPV
Arm Type
Active Comparator
Arm Description
The patients will receive conventional-intensity noninvasive positive pressure ventilation.
Intervention Type
Device
Intervention Name(s)
High-intensity NPPV
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional-intensity NPPV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intubation rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The decrements of PaCO2 measured at 2 hours after enrollment.
Time Frame
2 hours
Title
The decrements of PaCO2 measured at 6 hours after enrollment.
Time Frame
6 hours
Title
The decrements of PaCO2 measured at 24 hours after enrollment.
Time Frame
24 hours
Title
The decrements of PaCO2 measured at 48 hours after enrollment.
Time Frame
48 hours
Title
ICU mortality rate
Time Frame
1 year
Title
28-day mortality rate
Time Frame
28 days
Title
Hospital survival rate
Time Frame
1 year
Title
90-day mortality rate
Time Frame
90 days
Title
ICU length of stay
Time Frame
1 year
Title
Hospital length of stay
Time Frame
1 year
Title
Complication related to NPPV
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zujin Luo, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Baoji
City
Baoji
Country
China
Facility Name
The Third Hospital of Baoji
City
Baoji
Country
China
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
Country
China
Facility Name
Beijing Mentougou District Hospital
City
Beijing
Country
China
Facility Name
Beijing Pinggu Hospital
City
Beijing
Country
China
Facility Name
Beijing Renhe Hospital
City
Beijing
Country
China
Facility Name
People's Hospital of Beijing Huairou District
City
Beijing
Country
China
Facility Name
Chongqing Xin-Qiao Hospital
City
Chongqing
Country
China
Facility Name
Gongyi City People's Hospital
City
Gongyi
Country
China
Facility Name
Haicheng Central Hospital
City
Haicheng
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
People's Hospital of Hanshou
City
Hanshou
Country
China
Facility Name
The First Hospital of University of South China
City
Hengyang
Country
China
Facility Name
The Second Hospital of University of South China
City
Hengyang
Country
China
Facility Name
The Affiliated Hospital of Henan Polytechnic University
City
Jiaozuo
Country
China
Facility Name
Kaifeng Central Hospital
City
Kaifeng
Country
China
Facility Name
The First Affiliated Hospital of Henan University
City
Kaifeng
Country
China
Facility Name
The Affiliated Hospital of Kunming University of Science and Technology
City
Kunming
Country
China
Facility Name
The Third Hospital of Mianyang
City
Mianyang
Country
China
Facility Name
National Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
Country
China
Facility Name
Nanyang Central Hospital
City
Nanyang
Country
China
Facility Name
Sanmenxia Central Hospital
City
Sanmenxia
Country
China
Facility Name
The Affiliated Hospital of North China University of Science of Technology
City
Tangshan
Country
China
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xian
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30463622
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.
Results Reference
derived

Learn more about this trial

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

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