Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Acute Respiratory Failure Clinical Trial

Official title:

Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02983851
• Other study ID #: VENIM
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2016
• Last updated: December 2, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: Peking Union Medical College Hospital
• Contact: Yi Li, M.D.
• Phone: 13693109826
• Email: billliyi[@]126.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 238
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Immunocompromised Patients
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (19)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day all-cause mortality		the 30th day after patient inclusion in the study	No
Secondary	In-hospital mortality		through study study completion, an average of 2 years	No
Secondary	Length of stay in hospital		through study study completion, an average of 2 years	No
Secondary	Length of mechanical ventilation		through study study completion, an average of 2 years	No
Secondary	Nosocomial infections		through study study completion, an average of 2 years	No