Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— BiRDS  

Official title:

Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01862016
• Other study ID #: PHRC 2009-04
• Secondary ID: 2012-A00551-42
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2013
• Est. completion date: May 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients.

The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 702
• Est. completion date: May 2019
• Est. primary completion date: December 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Within 1 week of a known clinical insult or new or worsening respiratory symptoms

• Intubation and mechanical ventilation

• Bilateral opacities — not fully explained by effusions, lobar/lung collapse, or nodules lung

• Report PaO2 / FiO2 = 200 mmHg with a PEP of at least 5 cmH2O

• Respiratory failure not fully explained by cardiac failure or fluid overload

• Criteria 1, 2 and 3 presents jointly for less than 48 hours

• Consent to participate obtained either from the patient himself or from a relative.

Exclusion Criteria:

• Age < 18 years

• Pregnancy

• Predictable duration of the mechanical ventilation on endotracheal tube lower than 48 hours

• Patient being in period of exclusion further to the participation in another biomedical study

• intracranial hypertension (suspected or confirmed)

• known or suspected COPD

• Chronic respiratory failure treated by long-term oxygen and / or long-term respiratory support

• Morbid obesity defined as weight greater than 1 kg / cm

• Sickle Cell Disease

• Marrow recent transplant, post-chemotherapy aplasia

• Widened burns (> 30% body surface area)

• Severe hepatic cirrhosis (Child-Pugh C)

• Pneumothorax (drained or not)

• Treatment with extracorporeal support (ECMO)

• Decision of active therapeutic limitation

• Unavailability of the model of respirator that must be used in the study

• Failure to obtain a consent by persons authorized to do so.

• Patient under law protection.

• Person non-beneficiary of a social security system

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Aspiration
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• APRV
Pressure ventilation mode allowing early spontaneous breathing

Biological:
• arterial blood gas measurement each morning

Locations

Country	Name	City	State
France	Medical Intensive Care Unit, University Hospital of Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause hospital mortality	participants will be followed for the duration of hospital stay, until day 60 maximum.	hospital discharge
Secondary	all causes mortality		Day 28
Secondary	number of days alive without mechanical ventilation		day 28
Secondary	number of days alive without organ failure		day 28
Secondary	number of patients with refractory hypoxemia		day 7
Secondary	number of patients requiring adjuvant treatment of hypoxemia		day 7
Secondary	number of days alive without sedation		Day 28
Secondary	total amount of sedative drugs		between baseline and day 7
Secondary	amount of sedative drugs received daily living		between baseline and day 7
Secondary	number of days alive without vasoactive drugs		day 28
Secondary	total amount of vasoactive drugs		between baseline and day 7
Secondary	amount of vasoactive drugs received daily living		between baseline and day 7
Secondary	Number of patients with a pneumothorax		day 28
Secondary	Duration of mechanical ventilation		day 60
Secondary	Duration of stay in ICU		day 60
Secondary	Changes in serum levels of proinflammatory cytokines		Hour 1 and Hour 48