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Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

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ClinicalTrials.gov Identifier: NCT02983851
Recruitment Status : Not yet recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Collaborators:
National Natural Science Foundation of China
Ministry of Health, China
Fujian Provincial Hospital
The First Affiliated Hospital of Kunming Medical College
First Affiliated Hospital, Sun Yat-Sen University
Renmin Hospital of Wuhan University
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital with Nanjing Medical University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Anhui Medical University
The Affiliated Hospital Of Guizhou Medical University
The Affiliated Hospital of Inner Mongolia Medical University
General Hospital of Ningxia Medical University
Tianjin Medical University General Hospital
Second Xiangya Hospital of Central South University
The Second Affiliated Hospital of Harbin Medical University
Cangzhou Central Hospital
the first hospital of Handan
Information provided by (Responsible Party):
Yi Li, MD, Peking Union Medical College Hospital

Brief Summary:
VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying the initial ventilation strategy for adult immunocompromised patients with acute respiratory failure.

Condition or disease Intervention/treatment Phase
Immunocompromised Patients Acute Respiratory Failure Procedure: Noninvasive mechanical ventilation Procedure: Invasive mechanical ventilation Not Applicable

Detailed Description:
The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with moderate to severe acute respiratory failure (ARF). Patients who meet the indications for both ventilatory supports will be included. The intervention will consist of randomly allocation, treatment with NIV or IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity, causes of immunodeficiency and types of ARF will also be analyzed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Active Comparator: 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.
Procedure: 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.




Primary Outcome Measures :
  1. 30-day all-cause mortality [ Time Frame: the 30th day after patient inclusion in the study ]

Secondary Outcome Measures :
  1. In-hospital mortality [ Time Frame: through study study completion, an average of 2 years ]
  2. Length of stay in hospital [ Time Frame: through study study completion, an average of 2 years ]
  3. Length of mechanical ventilation [ Time Frame: through study study completion, an average of 2 years ]
  4. Nosocomial infections [ Time Frame: through study study completion, an average of 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18 years old ≤ age ≤ 80 years old) immunocompromised patients admitted to hospital with moderate to severe ARF diagnosed within the last 72 hours, which meets the indications for ventilatory support.
  • 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:

  • Age<18 or >80 years old;
  • 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

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): NCT02983851


Contacts
Contact: Yi Li, M.D. 13693109826 billliyi@126.com

Sponsors and Collaborators
Peking Union Medical College Hospital
National Natural Science Foundation of China
Ministry of Health, China
Fujian Provincial Hospital
The First Affiliated Hospital of Kunming Medical College
First Affiliated Hospital, Sun Yat-Sen University
Renmin Hospital of Wuhan University
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital with Nanjing Medical University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Anhui Medical University
The Affiliated Hospital Of Guizhou Medical University
The Affiliated Hospital of Inner Mongolia Medical University
General Hospital of Ningxia Medical University
Tianjin Medical University General Hospital
Second Xiangya Hospital of Central South University
The Second Affiliated Hospital of Harbin Medical University
Cangzhou Central Hospital
the first hospital of Handan
Investigators
Study Chair: Yi Li, M.D. PUMC hospital,Chinese Academy of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yi Li, MD, Chief physician of Emergency Department, professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02983851     History of Changes
Other Study ID Numbers: VENIM
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yi Li, MD, Peking Union Medical College Hospital:
Noninvasive mechanical ventilation
Invasive mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases