Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Conditions
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Immunocompromised Patients, Acute Respiratory Failure

Intervention / Treatment
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* Procedure: Noninvasive mechanical ventilation
* Procedure: Invasive mechanical ventilation


Participation Criteria
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Eligibility Criteria
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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: 30 mmHg < PaO2 < 50 mmHg on room air; 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: HIV infection; Hematologic malignancy or solid tumor under chemotherapy; Solid organ or stem cell transplant; Long-term (>30 days) or high dose steroids (>1 mg/kg/d prednisone equivalent) usage and/or any other immunosuppressive drugs; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive mechanical ventilation<br>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<br>* Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.<br>|
| Active Comparator: Invasive mechanical ventilation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day all-cause mortality |  | the 30th day after patient inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | through study study completion, an average of 2 years | 
| Length of stay in hospital |  | through study study completion, an average of 2 years | 
| Length of mechanical ventilation |  | through study study completion, an average of 2 years | 
| Nosocomial infections |  | through study study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive mechanical ventilation, Invasive mechanical ventilation