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The trial has been terminated by the DSMB and the trial steering committee, based on the interim analysis results and the impracticality of continuing the trial in the context of the coronavirus disease 2019 (COVID-19) pandemic.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity NPPV | Experimental | Patients will receive high-intensity NPPV. |
|
| Low-intensity NPPV | Active Comparator | Patients will receive low-intensity NPPV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity NPPV | Device | In the high-intensity NPPV group, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O, typically ranging from 20 to 30 cmH2O (or a tolerated maximum), to obtain a VT 10-15 mL/kg PBW and a respiratory rate <25 breaths/min. Subsequent adjustments to IPAP are based on the results of arterial blood gases (ABGs; up to 30 cmH2O) to achieve normocapnia (if possible), or to maximally decrease PaCO2 toward normocapnia if normocapnia can not be achieved. If PaCO2 decreases to less than 35 mmHg, IPAP will be decreased to achieve normocapnia. |
| Measure | Description | Time Frame |
|---|---|---|
| The need for endotracheal intubation during hospitalization | Defined as the proportion of patients who needed for endotracheal intubation during hospitalization after randomization | From randomization to discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Actual intubation during hospitalization | Defined as the proportion of patients actually receiving intubation and invasive ventilation during hospitalization after randomization | From randomization to discharge from hospital |
| Need for endotracheal intubation at day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zujin Luo, MD | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuyuan Hospital of Inner Mongolia | Bayan Nur | China | ||||
| Beijing Chao-Yang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39283649 | Derived | Luo Z, Li Y, Li W, Li Y, Nie Q, Shi Y, Wang J, Ji Q, Han X, Liu S, Li D, Wang S, Li Z, Jia D, Ge H, Xu P, Feng Z, Li F, An F, Tai N, Yue L, Xie H, Jin X, Liu H, Dang Q, Zhang Y, Sun L, Wang J, Huang H, Chen L, Ma Y, Cao Z, Wang C; HAPPEN Investigators. 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. JAMA. 2024 Nov 26;332(20):1709-1722. doi: 10.1001/jama.2024.15815. | |
| 30463622 |
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|
| Low-intensity NPPV | Device | In the low-intensity NPPV group, as well as during the 6-hour trial of low-intensity NPPV, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT 6-10 mL/kg PBW and a respiratory rate <25 breaths/min. Subsequent adjustments to IPAP are based on the results of ABGs (up to 20 cmH2O) to achieve a pH of ≥7.35 and to reduce PaCO2 to a level deemed appropriate by the attending physician. |
|
Defined as the proportion of patients who needed endotracheal intubation within 28 days since randomization |
| Within 28 days since randomization |
| Actual intubation at day 28 | Defined as the proportion of patients receiving intubation and invasive ventilation within 28 days after randomization | Within 28 days since randomization |
| The composite of actual intubation or avoiding intubation by crossover to high-intensity NPPV | Defined as the incidence of patients receiving actual intubation in the high-intensity NPPV group vs the composite incidence of actual intubation or avoiding intubation by crossover to high-intensity NPPV in case of intubation criteria in the low-intensity NPPV group) during hospitalization after randomization | From randomization to discharge from hospital |
| NPPV weaning success | Defined as the proportion of patients with persistent disconnection of NPPV without the presence of respiratory distress within the following 72 hours during hospitalization after randomization | From randomization to discharge from hospital |
| Mortality in hospital | From randomization to discharge from hospital |
| Mortality at day 28 | Within 28 days since randomization |
| Mortality at day 90 | Within 90 days since randomization |
| Intensive care unit admission | Defined as the proportion of patients who transferred to ICU during hospitalization after randomization | From randomization to discharge from hospital |
| Live discharge from the hospital | Defined as the proportion of patients with the exception of those who died and withdrawn treatment therapy during hospitalization after randomization. | From randomization to discharge from hospital |
| Length of hospital stay | Defined as the number of days for the index hospitalization | From hospital admission to discharge |
| Length of hospital stay after randomization | Defined as the number of hospitalization days since randomization | From randomization to discharge from hospital |
| Invasive ventilator-free days at day 28 | Defined as 28 minus the number of days with invasive ventilator (range, 0-28 days) since randomization | Within 28 days since randomization |
| ICU-free days at day 28 | Defined as 28 minus the number of days in the ICU (range, 0-28 days) since randomization | Within 28 days since randomization |
| Hospital readmission at day 90 | Defined as the number of hospitalization days within 90 days since randomization | Within 90 days since randomization |
| Beijing |
| China |
| Beijing Fangshan Liangxiang Hospital, | Beijing | China |
| Beijing Jingmei Group General Hospital | Beijing | China |
| Beijing Luhe Hospital | Beijing | China |
| Beijing Mentougou District Hospital | Beijing | China |
| Beijing Pinggu Hospital | Beijing | China |
| Beijing Zhongguancun Hospital | Beijing | China |
| Capital Medical University Daxing Teaching Hospital | Beijing | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| Dalian Friendship Hospital | Dalian | China |
| Dalian Municipal Central Hospital | Dalian | China |
| Shulan (Hang Zhou) Hospital | Hangzhou | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | China |
| Hemei General Hospital | Hebi | China |
| Huangshi Central Hospital | Huangshi | China |
| Jiaozuo People's Hospital | Jiaozuo | China |
| Jiaozuo Second Hospital | Jiaozuo | China |
| Kaifeng Central Hospital | Kaifeng | China |
| The First Affiliated Hospital of Hanan University, | Kaifeng | China |
| The First People's Hospital of Luoyang | Luoyang | China |
| The Third Hospital of Mianyang | Mianyang | China |
| Nanyang Central Hospital | Nanyang | China |
| Nanyang First People's Hospital | Nanyang | China |
| Sanmenxia Central Hospital | Sanmenxia | China |
| The Second Hospital of Tongliao | Tongliao | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | China |
| Xinxiang Central Hospital | Xinxiang | China |
| Zhengzhou Central Hospital | Zhengzhou | China |
| Hunan Province Directly Affiliated TCM Hospital | Zhuzhou | China |
| Zibo First Hospital | Zibo | China |
| Derived |
| 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. |