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Early Spontaneous Breathing in Acute Respiratory Distress Syndrome (BiRDS)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
APRV
arterial blood gas measurement each morning
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, APRV ventilatory mode, Spontaneous breathing, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Intensive Care Unit, University Hospital of Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

VAC mode, Controlled ventilation

APRV mode, Spontaneous breathing

Arm Description

From randomization, patients are put under controlled ventilation with specific settings

During 1 to 3 hours after randomization, patients are put under controlled ventilation with specific settings for baseline data. After that, they are placed under APRV mode with specific settings

Outcomes

Primary Outcome Measures

all cause hospital mortality
participants will be followed for the duration of hospital stay, until day 60 maximum.

Secondary Outcome Measures

all causes mortality
number of days alive without mechanical ventilation
number of days alive without organ failure
number of patients with refractory hypoxemia
number of patients requiring adjuvant treatment of hypoxemia
number of days alive without sedation
total amount of sedative drugs
amount of sedative drugs received daily living
number of days alive without vasoactive drugs
total amount of vasoactive drugs
amount of vasoactive drugs received daily living
Number of patients with a pneumothorax
Duration of mechanical ventilation
Duration of stay in ICU
Changes in serum levels of proinflammatory cytokines

Full Information

First Posted
May 17, 2013
Last Updated
March 15, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01862016
Brief Title
Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
Acronym
BiRDS
Official Title
Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2013 (Actual)
Primary Completion Date
December 16, 2017 (Actual)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute respiratory distress syndrome, APRV ventilatory mode, Spontaneous breathing, Intensive Care Unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
702 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAC mode, Controlled ventilation
Arm Type
Active Comparator
Arm Description
From randomization, patients are put under controlled ventilation with specific settings
Arm Title
APRV mode, Spontaneous breathing
Arm Type
Experimental
Arm Description
During 1 to 3 hours after randomization, patients are put under controlled ventilation with specific settings for baseline data. After that, they are placed under APRV mode with specific settings
Intervention Type
Procedure
Intervention Name(s)
APRV
Intervention Description
Pressure ventilation mode allowing early spontaneous breathing
Intervention Type
Biological
Intervention Name(s)
arterial blood gas measurement each morning
Primary Outcome Measure Information:
Title
all cause hospital mortality
Description
participants will be followed for the duration of hospital stay, until day 60 maximum.
Time Frame
hospital discharge
Secondary Outcome Measure Information:
Title
all causes mortality
Time Frame
Day 28
Title
number of days alive without mechanical ventilation
Time Frame
day 28
Title
number of days alive without organ failure
Time Frame
day 28
Title
number of patients with refractory hypoxemia
Time Frame
day 7
Title
number of patients requiring adjuvant treatment of hypoxemia
Time Frame
day 7
Title
number of days alive without sedation
Time Frame
Day 28
Title
total amount of sedative drugs
Time Frame
between baseline and day 7
Title
amount of sedative drugs received daily living
Time Frame
between baseline and day 7
Title
number of days alive without vasoactive drugs
Time Frame
day 28
Title
total amount of vasoactive drugs
Time Frame
between baseline and day 7
Title
amount of vasoactive drugs received daily living
Time Frame
between baseline and day 7
Title
Number of patients with a pneumothorax
Time Frame
day 28
Title
Duration of mechanical ventilation
Time Frame
day 60
Title
Duration of stay in ICU
Time Frame
day 60
Title
Changes in serum levels of proinflammatory cytokines
Time Frame
Hour 1 and Hour 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical Intensive Care Unit, University Hospital of Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

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Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

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