Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02983851|
Recruitment Status : Not yet recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immunocompromised Patients Acute Respiratory Failure||Procedure: Noninvasive mechanical ventilation Procedure: Invasive mechanical ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 30-day all-cause mortality [ Time Frame: the 30th day after patient inclusion in the study ]
- In-hospital mortality [ Time Frame: through study study completion, an average of 2 years ]
- Length of stay in hospital [ Time Frame: through study study completion, an average of 2 years ]
- Length of mechanical ventilation [ Time Frame: through study study completion, an average of 2 years ]
- Nosocomial infections [ Time Frame: through study study completion, an average of 2 years ]
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
|Contact: Yi Li, M.D.||firstname.lastname@example.org|
|Study Chair:||Yi Li, M.D.||PUMC hospital,Chinese Academy of Medical Sciences|