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Trial record 57 of 45988 for:    intensity

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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ClinicalTrials.gov Identifier: NCT02985918
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Zujin Luo, Beijing Chao Yang Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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.




Primary Outcome Measures :
  1. Intubation rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The decrements of PaCO2 measured at 2 hours after enrollment. [ Time Frame: 2 hours ]
  2. The decrements of PaCO2 measured at 6 hours after enrollment. [ Time Frame: 6 hours ]
  3. The decrements of PaCO2 measured at 24 hours after enrollment. [ Time Frame: 24 hours ]
  4. The decrements of PaCO2 measured at 48 hours after enrollment. [ Time Frame: 48 hours ]
  5. ICU mortality rate [ Time Frame: 1 year ]
  6. 28-day mortality rate [ Time Frame: 28 days ]
  7. Hospital survival rate [ Time Frame: 1 year ]
  8. 90-day mortality rate [ Time Frame: 90 days ]
  9. ICU length of stay [ Time Frame: 1 year ]
  10. Hospital length of stay [ Time Frame: 1 year ]
  11. Complication related to NPPV [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985918


Contacts
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Contact: Zujin Luo, MD 86-10-1381-497587 xmjg2002@163.com

Locations
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China
The Second Hospital of Baoji Recruiting
Baoji, China
Contact: Xinghui Wu, MD         
The Third Hospital of Baoji Recruiting
Baoji, China
Contact: Zhifang Liu, MD         
Beijing Chao-Yang Hospital Recruiting
Beijing, China
Contact: Zujin Luo, MD         
Beijing Mentougou District Hospital Recruiting
Beijing, China
Contact: Fucheng An, MD         
Beijing Pinggu Hospital Recruiting
Beijing, China
Contact: Hongru Liu, MD         
Beijing Renhe Hospital Recruiting
Beijing, China
Contact: Yongxiang Zhang, MD         
People's Hospital of Beijing Huairou District Recruiting
Beijing, China
Contact: Xiuhong Ma, MD         
Chongqing Xin-Qiao Hospital Recruiting
Chongqing, China
Contact: Qi Li, MD         
Gongyi City People's Hospital Recruiting
Gongyi, China
Contact: Wenshuai Feng, MD         
Haicheng Central Hospital Recruiting
Haicheng, China
Contact: Ling Yu, MD         
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, China
Contact: Huiqing Ge, MD         
People's Hospital of Hanshou Recruiting
Hanshou, China
Contact: Longguang Wu, MD         
The First Hospital of University of South China Recruiting
Hengyang, China
Contact: Yaoming Hu, MD         
The Second Hospital of University of South China Recruiting
Hengyang, China
Contact: Lin Chen, MD         
The Affiliated Hospital of Henan Polytechnic University Recruiting
Jiaozuo, China
Contact: Xianglian Guo, MD         
Kaifeng Central Hospital Recruiting
Kaifeng, China
Contact: Yongpeng An, MD         
The First Affiliated Hospital of Henan University Recruiting
Kaifeng, China
Contact: Zhijun Liu, MD         
The Affiliated Hospital of Kunming University of Science and Technology Recruiting
Kunming, China
Contact: Yunhui Lv, MD         
The Third Hospital of Mianyang Recruiting
Mianyang, China
Contact: Kailv Wang, MD         
National Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, China
Contact: Yonghong Xiang, MD         
Nanyang Central Hospital Recruiting
Nanyang, China
Contact: Qiang Dang, MD         
Sanmenxia Central Hospital Recruiting
Sanmenxia, China
Contact: Dongmei Li, MD         
The Affiliated Hospital of North China University of Science of Technology Recruiting
Tangshan, China
Contact: Chen Liu, MD         
People's Hospital of Xinjiang Uygur Autonomous Region Recruiting
Urumqi, China
Contact: Chao Wu, MD         
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, China
Contact: Mingwei Chen, MD         
The First Affiliated Hospital of Xi'an Medical University Recruiting
Xian, China
Contact: Shengyu Wang, MD         
The Second Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, China
Contact: Runxia Shao, MD         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Zujin Luo, MD Beijing Chao Yang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zujin Luo, Principal Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02985918     History of Changes
Other Study ID Numbers: BeijingCYH-ICU-004
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases