Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Immunocompromised Patients; Acute Respiratory Failure

Treatments: Procedure: Noninvasive mechanical ventilation; Procedure: Invasive mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02983851

VENIM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 2 patient groups

Noninvasive mechanical ventilation

Experimental group

Description:

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.

Treatment:

Procedure: Noninvasive mechanical ventilation

Invasive mechanical ventilation

Active Comparator group

Description:

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.

Treatment:

Procedure: Invasive mechanical ventilation