Evidence map›Paper›PMID 25257210›Full record

Trial reportTrials2014

Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial.

Virginie Lemiale, Matthieu Resche-Rigon, Elie Azoulay, Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Réanimation Respiratoire du patient d’Onco-Hématologie

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01915719 (Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01915719 nacompletednot on this map

Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2013 to 2016Enrolled374ConditionsAdult, Acute Respiratory Failure Admitted in ICU, Immuno CompromizedArmsEarly non invasive ventilation, Oxygen therapy only
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Invasive and non-invasive mechanical ventilation.Medicine (Abingdon, England : UK ed.) · 2016
    Review
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Virginie LemialeMedical ICU, Assistance Publique Hopitaux de Paris, St Louis Hospital, 1 avenue Claude Vellefaux, 75010 Paris, France. virginie.lemiale@sls.aphp.fr.
Matthieu Resche-Rigon
Elie Azoulay
Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Réanimation Respiratoire du patient d’Onco-Hématologie
Assistance Publique – Hôpitaux de Paris · FRDélégation Paris 7 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute respiratory failure (ARF) remains the leading reason for intensive care unit (ICU) admission of immunocompromised patients. In the most severe cases, high-flow oxygen therapy may fail to ensure adequate gas exchange, and mechanical ventilation (MV) must be used. This scenario is associated with high mortality rates of 40 to 60%, depending on the cause of ARF and type of immune deficiency. The use of non-invasive ventilation (NIV) in this situation has been criticized as potentially delaying the initiation of optimal treatment. In contrast, early NIV used prophylactically in patients with ARF who do not meet the criteria for invasive MV (IMV) may obviate the need for IMV, thereby decreasing the morbidity and mortality rates. We aim to demonstrate that a management strategy including early NIV decreases 28-day mortality rates compared to oxygen therapy alone in immunocompromised patients with ARF. METHODS/

designThis is a multicenter parallel-group randomized controlled trial comparing early NIV to oxygen therapy alone in immunocompromised patients with ARF. All immunocompromised adult patients admitted to admission for ARF are eligible for randomization. Patient with ARF onset more than 72 hours earlier or ARF related to cardiogenic pulmonary edema or hypercapnia, or with a need for immediate endotracheal intubation or other organ failure are not eligible.After inclusion patient are allocated to receive early NIV (intervention arm) or oxygen therapy only (control arm).We plan to enroll 374 patients in 29 ICUs. An interim analysis is planned after the inclusion of 187 patients. The main objective is to demonstrate early NIV increases survival as compared to oxygen therapy alone. Other outcomes include the need of IMV, organ failure evolution, nosocomial infections rate, 6 months survival. DISCUSSION: This study is expected to demonstrate an improved 28-day survival in immunocompromised patients managed with early NIV.

trial registrationREGISTRATION NUMBER: Clinicaltrials.gov NCT01915719. Registered on 26 July 2013.

Indexed as

Immunocompromised HostNoninvasive VentilationOxygen Inhalation TherapyResearch DesignAcute DiseaseClinical ProtocolsFranceHumansIntensive Care UnitsProspective StudiesRespiratory InsufficiencyRisk FactorsTime FactorsTreatment Outcome

Identifiers

PMID25257210
PMCPMC4190291
OpenAlexW2153706108

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.