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Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Primary Purpose

Immunocompromised Patients, Acute Respiratory Failure

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Noninvasive mechanical ventilation

Invasive mechanical ventilation

About this trial

This is an interventional treatment trial for Immunocompromised Patients focused on measuring Noninvasive mechanical ventilation, Invasive mechanical ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Noninvasive mechanical ventilation

Invasive mechanical ventilation

Arm 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.

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.

Outcomes

Primary Outcome Measures

30-day all-cause mortality

Secondary Outcome Measures

In-hospital mortality

Length of stay in hospital

Length of mechanical ventilation

Nosocomial infections

Full Information

NCT ID

NCT02983851

First Posted

November 25, 2016

Last Updated

December 2, 2016

Sponsor

Peking Union Medical College Hospital

Collaborators

National Natural Science Foundation of China, Ministry of Health, China, Fujian Provincial Hospital, First Affiliated Hospital of Kunming Medical University, 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, Handan First Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02983851

Brief Title

Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Official Title

Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunocompromised Patients, Acute Respiratory Failure

Keywords

Noninvasive mechanical ventilation, Invasive mechanical ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Noninvasive mechanical ventilation

Arm Type

Experimental

Arm Description

Arm Title

Invasive mechanical ventilation

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Noninvasive mechanical ventilation

Intervention Description

Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.

Intervention Type

Procedure

Intervention Name(s)

Invasive mechanical ventilation

Intervention Description

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.

Primary Outcome Measure Information:

Title

30-day all-cause mortality

Time Frame

the 30th day after patient inclusion in the study

Secondary Outcome Measure Information:

Title

In-hospital mortality

Time Frame

through study study completion, an average of 2 years

Title

Length of stay in hospital

Time Frame

through study study completion, an average of 2 years

Title

Length of mechanical ventilation

Time Frame

through study study completion, an average of 2 years

Title

Nosocomial infections

Time Frame

through study study completion, an average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Li, M.D.

Phone

13693109826

billliyi@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Li, M.D.

Organizational Affiliation

PUMC hospital,Chinese Academy of Medical Sciences

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28931394

Citation

Wang T, Liu G, He K, Lu X, Liang X, Wang M, Zhu R, Li Z, Chen F, Ke J, Lin Q, Qian C, Li B, Wei J, Lv J, Li L, Gao Y, Wu G, Yu X, Wei W, Deng Y, Wang F, Zhang H, Zheng Y, Zhan H, Liao J, Tian Y, Yao D, Zhang J, Chen X, Yang L, Wu J, Chai Y, Shou S, Yu M, Xiang X, Zhang D, Chen F, Xie X, Li Y, Wang B, Zhang W, Miao Y, Eddleston M, He J, Ma Y, Xu S, Li Y, Zhu H, Yu X. The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM). BMC Pulm Med. 2017 Sep 20;17(1):127. doi: 10.1186/s12890-017-0467-6.

Results Reference

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Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

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