Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
NCT ID: NCT02983851
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
238 participants
INTERVENTIONAL
2016-12-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Noninvasive mechanical ventilation
Patients in this group will receive Noninvasive mechanical ventilation as the initial mechanical ventilation (MV) strategy, irrespective of whether Invasive mechanical ventilation is used later during the following treatment.
Noninvasive mechanical ventilation
Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.
Invasive mechanical ventilation
Patients in this group will receive Invasive mechanical ventilation as the initial MV strategy, irrespective of whether Noninvasive mechanical ventilation is used later during the following treatment.
Invasive mechanical ventilation
Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.
Interventions
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Noninvasive mechanical ventilation
Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.
Invasive mechanical ventilation
Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.
Eligibility Criteria
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Inclusion Criteria
* Patients are considered as moderate to severe ARF when the ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) is between 85 and 170 while the patient is breathing oxygen through a Venturi mask, or clinically diagnosed as the following:
1. 30 mmHg \< PaO2 \< 50 mmHg on room air;
2. Clinical evidence of respiratory distress (intercostal recession, polypnea \>35/min or dyspnea at rest).
* Patients are considered as immunocompromised when clinically diagnosed as at least one of the following:
1. HIV infection;
2. Hematologic malignancy or solid tumor under chemotherapy;
3. Solid organ or stem cell transplant;
4. Long-term (\>30 days) or high dose steroids (\>1 mg/kg/d prednisone equivalent) usage and/or any other immunosuppressive drugs;
5. Neutropenia (defined as a neutrocyte count of \< 0.50×109/L) showing for at least 48 hours
Exclusion Criteria
* Partial pressure of arterial carbon dioxide (PaCO2) \> 50 mmHg or arterial pH \< 7.20;
* PaO2/FiO2 \>170 or PaO2/FiO2\< 85;
* Patients have been treated with NIV or IMV within 30 days.
* NIV is contraindicated or IMV is definitely indicated, including PaO2/FiO2\< 85, respiratory arrest, hemodynamic instability, inability to fit the face mask, pneumothorax, vomiting, development of airway bleeding, inability to protect the airway, or copious respiratory secretions;
* Comorbided with other severe diseases, including New York Heart Association functional class ≥ II, valvular heart disease, dilated cardiomyopathy, cardiogenic pulmonary edema, implanted cardiac pacemaker, unstable angina, myocardial infarction, or cardiac surgery within the previous 3 months; systolic arterial pressure \<90 mmHg after optimal fluid therapy; history of chronic obstructive pulmonary disease (COPD) or asthma; impaired consciousness (Glasgow Coma Scale score \<13); postoperative acute respiratory failure; pregnancy or breastfeeding;
* Lack of consent, do-not-intubate decision, and any other situations where obvious bias are expected
18 Years
80 Years
ALL
No
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
Ministry of Health, China
OTHER_GOV
Fujian Provincial Hospital
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Renmin Hospital of Wuhan University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
General Hospital of Ningxia Medical University
OTHER
Tianjin Medical University General Hospital
OTHER
Second Xiangya Hospital of Central South University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Cangzhou Central Hospital
OTHER
Handan First Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Yi Li, MD
Chief physician of Emergency Department, professor
Principal Investigators
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Yi Li, M.D.
Role: STUDY_CHAIR
PUMC hospital,Chinese Academy of Medical Sciences
Central Contacts
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References
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Wang T, Liu G, He K, Lu X, Liang X, Wang M, Zhu R, Li Z, Chen F, Ke J, Lin Q, Qian C, Li B, Wei J, Lv J, Li L, Gao Y, Wu G, Yu X, Wei W, Deng Y, Wang F, Zhang H, Zheng Y, Zhan H, Liao J, Tian Y, Yao D, Zhang J, Chen X, Yang L, Wu J, Chai Y, Shou S, Yu M, Xiang X, Zhang D, Chen F, Xie X, Li Y, Wang B, Zhang W, Miao Y, Eddleston M, He J, Ma Y, Xu S, Li Y, Zhu H, Yu X. The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM). BMC Pulm Med. 2017 Sep 20;17(1):127. doi: 10.1186/s12890-017-0467-6.
Other Identifiers
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VENIM
Identifier Type: -
Identifier Source: org_study_id