Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02983851

Collaborator

National Natural Science Foundation of China (Other), Ministry of Health, China (Other), Fujian Provincial Hospital (Other), The First Affiliated Hospital of Kunming Medical College (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), Renmin Hospital of Wuhan University (Other), The First Affiliated Hospital of Zhengzhou University (Other), The First Affiliated Hospital with Nanjing Medical University (Other), The Second Hospital of Hebei Medical University (Other), The First Affiliated Hospital of Anhui Medical University (Other), The Affiliated Hospital Of Guizhou Medical University (Other), The Affiliated Hospital of Inner Mongolia Medical University (Other), General Hospital of Ningxia Medical University (Other), Tianjin Medical University General Hospital (Other), Second Xiangya Hospital of Central South University (Other), The Second Affiliated Hospital of Harbin Medical University (Other), Cangzhou Central Hospital (Other), the first hospital of Handan (Other)

238

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

30-day all-cause mortality [the 30th day after patient inclusion in the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi Li, MD, Chief physician of Emergency Department, professor, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT02983851

Other Study ID Numbers:

VENIM

First Posted:

Dec 6, 2016

Last Update Posted:

Dec 6, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Yi Li, MD, Chief physician of Emergency Department, professor, Peking Union Medical College Hospital

Noninvasive mechanical ventilation

Invasive mechanical ventilation

Additional relevant MeSH terms:

Respiratory Insufficiency

Respiratory Distress Syndrome

Study Results

No Results Posted as of Dec 6, 2016