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Early Spontaneous Breathing in Acute Respiratory Distress Syndrome (BiRDS)

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ClinicalTrials.gov Identifier: NCT01862016
Recruitment Status : Unknown
Verified March 2019 by University Hospital, Angers.
Recruitment status was:  Active, not recruiting
First Posted : May 24, 2013
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Procedure: APRV Biological: arterial blood gas measurement each morning Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
Actual Study Start Date : February 28, 2013
Actual Primary Completion Date : December 16, 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: VAC mode, Controlled ventilation
From randomization, patients are put under controlled ventilation with specific settings
 Biological: arterial blood gas measurement each morning
Experimental: APRV mode, Spontaneous breathing
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
 Procedure: APRV
Pressure ventilation mode allowing early spontaneous breathing

Biological: arterial blood gas measurement each morning


Outcome Measures
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Primary Outcome Measures :
  1. all cause hospital mortality [ Time Frame: hospital discharge ]
    participants will be followed for the duration of hospital stay, until day 60 maximum.


Secondary Outcome Measures :
  1. all causes mortality [ Time Frame: Day 28 ]
  2. number of days alive without mechanical ventilation [ Time Frame: day 28 ]
  3. number of days alive without organ failure [ Time Frame: day 28 ]
  4. number of patients with refractory hypoxemia [ Time Frame: day 7 ]
  5. number of patients requiring adjuvant treatment of hypoxemia [ Time Frame: day 7 ]
  6. number of days alive without sedation [ Time Frame: Day 28 ]
  7. total amount of sedative drugs [ Time Frame: between baseline and day 7 ]
  8. amount of sedative drugs received daily living [ Time Frame: between baseline and day 7 ]
  9. number of days alive without vasoactive drugs [ Time Frame: day 28 ]
  10. total amount of vasoactive drugs [ Time Frame: between baseline and day 7 ]
  11. amount of vasoactive drugs received daily living [ Time Frame: between baseline and day 7 ]
  12. Number of patients with a pneumothorax [ Time Frame: day 28 ]
  13. Duration of mechanical ventilation [ Time Frame: day 60 ]
  14. Duration of stay in ICU [ Time Frame: day 60 ]
  15. Changes in serum levels of proinflammatory cytokines [ Time Frame: Hour 1 and Hour 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862016


Locations
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France
Medical Intensive Care Unit, University Hospital of Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01862016    
Other Study ID Numbers: PHRC 2009-04
2012-A00551-42 ( Other Identifier: IDRCB number (ANSM) )
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by University Hospital, Angers:
Acute respiratory distress syndrome
APRV ventilatory mode
Spontaneous breathing
Intensive Care Unit
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury