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Status unknownNCT02983851Updated Dec 6, 2016

Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure

An interventional study of Noninvasive mechanical ventilation and Invasive mechanical ventilation in Immunocompromised Patients and Acute Respiratory Failure, sponsored by Peking Union Medical College Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-06.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immunocompromised Patients
  • Acute Respiratory Failure

Keywords

  • Noninvasive mechanical ventilation
  • Invasive mechanical ventilation
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 238 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
238 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureNoninvasive 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.

  • ProcedureInvasive 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.

06

What researchers measure

Primary outcomes

  1. 30-day all-cause mortality

    Time frame: the 30th day after patient inclusion in the study

Secondary outcomes

  1. In-hospital mortality

    Time frame: through study study completion, an average of 2 years

  2. Length of stay in hospital

    Time frame: through study study completion, an average of 2 years

  3. Length of mechanical ventilation

    Time frame: through study study completion, an average of 2 years

  4. Nosocomial infections

    Time frame: through study study completion, an average of 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 28931394 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02983851
Lead 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
Responsible party
Yi Li, MD (Chief physician of Emergency Department, professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Dec 6, 2016
Start date
Dec 2016
Primary completion
Sep 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Dec 6, 2016

Study contacts

Yi Li, M.D.
Contact
billliyi@126.com
13693109826
Yi Li, M.D.
study chair · PUMC hospital,Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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