Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.

Adult Clinical Trial

— IVNICTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915719
• Other study ID #: IVNICTUS
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: April 15, 2016
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: The Commission nationale de l’informatique et des libertésFrance: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age over 18 years old

• ICU admission

• Acute respiratory failure defined by (PaO2<60 mmHg at room air) or (polypnea >30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours.

• Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid > 1mg/kg/d or >1 month or other immunosuppressive treatment >1 month)

Exclusion Criteria:

• Hypercapnia >50 mmHg or increased of hypercapnia >10 mmHg under Oxygen treatment

• Need of immediate mechanical ventilation

• Obvious cardiogenic oedema

• Vasopressor use >0.03 µg/kg/min

• Glasgow Score <13

• End of life decision

• Acute myocardial infarction

• Patient refusal

• Pregnancy

• No national health insurance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure Admitted in ICU
• Adult
• Immuno Compromized
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• Early non invasive ventilation

• Oxygen therapy only

Locations

Country	Name	City	State
France	APHP, Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Lemiale V, Mokart D, Resche-Rigon M, Pène F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Théodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, — View Citation

Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Réanimation Respiratoire du patient d’Onco-Hématologie. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014 Sep 25;15:372. doi: 10.1186/1745-6215-15-372. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day 28 Mortality		Day 28	No
Secondary	Needs of mechanical ventilation		Day 28	No
Secondary	SOFA Score		Hour 72	No
Secondary	Nosocomial infection		day 28	Yes
Secondary	Length of stay in ICU		Day 28	No
Secondary	performance status (OMS scale ranging from 0-perfect status- to 4-moribund)		6 Months	No