NCT02983851

Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Immunocompromised Patients
• Acute Respiratory Failure

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2016-12-06
• Last updated: 2016-12-06