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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)

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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

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
Intubation rate [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02985918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • The decrements of PaCO2 measured at 2 hours after enrollment. [ Time Frame: 2 hours ]
  • The decrements of PaCO2 measured at 6 hours after enrollment. [ Time Frame: 6 hours ]
  • The decrements of PaCO2 measured at 24 hours after enrollment. [ Time Frame: 24 hours ]
  • The decrements of PaCO2 measured at 48 hours after enrollment. [ Time Frame: 48 hours ]
  • ICU mortality rate [ Time Frame: 1 year ]
  • 28-day mortality rate [ Time Frame: 28 days ]
  • Hospital survival rate [ Time Frame: 1 year ]
  • 90-day mortality rate [ Time Frame: 90 days ]
  • ICU length of stay [ Time Frame: 1 year ]
  • Hospital length of stay [ Time Frame: 1 year ]
  • Complication related to NPPV [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: the HAPPEN Study (HAPPEN)
Official Title  ICMJE High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: High-intensity NPPV
    The patients will receive high-intensity noninvasive positive pressure ventilation.
    Intervention: Device: High-intensity NPPV
  • Active Comparator: Conventional-intensity NPPV
    The patients will receive conventional-intensity noninvasive positive pressure ventilation.
    Intervention: Device: Conventional-intensity NPPV
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zujin Luo, MD 86-10-1381-497587 xmjg2002@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02985918
Other Study ID Numbers  ICMJE BeijingCYH-ICU-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zujin Luo, Beijing Chao Yang Hospital
Study Sponsor  ICMJE Beijing Chao Yang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zujin Luo, MD Beijing Chao Yang Hospital
PRS Account Beijing Chao Yang Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP