Acute Respiratory Distress SyndromeBiRDSNCT01862016
Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
A study testing APRV and arterial blood gas measurement each morning in people with Acute Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- APRV and arterial blood gas measurement each morning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2013to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Medical Intensive Care Unit, University Hospital of Angers
Angers, 49933
About this study
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- APRV, arterial blood gas measurement each morning
- Keywords
- Acute respiratory distress syndrome, APRV ventilatory mode, Spontaneous breathing, Intensive Care Unit
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APRVProcedure or surgery
Pressure ventilation mode allowing early spontaneous breathing
arterial blood gas measurement each morningBiological
| Study group | Role | What they receive |
|---|---|---|
| VAC mode, Controlled ventilation | Active comparator | From randomization, patients are put under controlled ventilation with specific settings Receives: Biological: arterial blood gas measurement each morning |
| APRV mode, Spontaneous breathing | Experimental | 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 Receives: Procedure: APRV; Biological: arterial blood gas measurement each morning |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause hospital mortality
participants will be followed for the duration of hospital stay, until day 60 maximum.
Measured: hospital discharge
Secondary outcomes (15)
all causes mortality
Measured: Day 28
number of days alive without mechanical ventilation
Measured: day 28
number of days alive without organ failure
Measured: day 28
number of patients with refractory hypoxemia
Measured: day 7
number of patients requiring adjuvant treatment of hypoxemia
Measured: day 7
number of days alive without sedation
Measured: Day 28
total amount of sedative drugs
Measured: between baseline and day 7
amount of sedative drugs received daily living
Measured: between baseline and day 7
number of days alive without vasoactive drugs
Measured: day 28
total amount of vasoactive drugs
Measured: between baseline and day 7
amount of vasoactive drugs received daily living
Measured: between baseline and day 7
Number of patients with a pneumothorax
Measured: day 28
Duration of mechanical ventilation
Measured: day 60
Duration of stay in ICU
Measured: day 60
Changes in serum levels of proinflammatory cytokines
Measured: Hour 1 and Hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start28 Feb 2013
- Primary completion16 Dec 2017
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862016
- Sponsor's protocol ID
- PHRC 2009-04
- Other IDs
- 2012-A00551-42
- Acronym
- BiRDS
- Status last verified
- Mar 2019
- First submitted
- 17 May 2013
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richard JM, Beloncle FM, Beduneau G, Mortaza S, Ehrmann S, Diehl JL, Prat G, Jaber S, Rahmani H, Reignier J, Boulain T, Yonis H, Richecoeur J, Thille AW, Declercq PL, Antok E, Carteaux G, Vielle B, Brochard L, Mercat A; REVA network. Pressure control plus spontaneous ventilation versus volume assist-control ventilation in acute respiratory distress syndrome. A randomised clinical trial. Intensive Care Med. 2024 Oct;50(10):1647-1656. doi: 10.1007/s00134-024-07612-3. Epub 2024 Sep 17.
PubMed 39287651
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01862016
- Acronym / sponsor ID
- BiRDS / PHRC 2009-04
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, APRV ventilatory mode, Spontaneous breathing, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 702 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 28 Feb 2013 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- May 2019 (estimated)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAC mode, Controlled ventilation | Active comparator | Biological: arterial blood gas measurement each morningFrom randomization, patients are put under controlled ventilation with specific settings |
| APRV mode, Spontaneous breathing | Experimental | Procedure: APRV, Biological: arterial blood gas measurement each morningDuring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APRVPressure ventilation mode allowing early spontaneous breathing | Procedure or surgery | APRV mode, Spontaneous breathing |
| arterial blood gas measurement each morning | Biological | APRV mode, Spontaneous breathing, VAC mode, Controlled ventilation |
Primary outcome
all cause hospital mortality
Time frame: hospital discharge
participants will be followed for the duration of hospital stay, until day 60 maximum.
15 secondary outcomes
all causes mortality
Time frame: Day 28
number of days alive without mechanical ventilation
Time frame: day 28
number of days alive without organ failure
Time frame: day 28
number of patients with refractory hypoxemia
Time frame: day 7
number of patients requiring adjuvant treatment of hypoxemia
Time frame: day 7
number of days alive without sedation
Time frame: Day 28
total amount of sedative drugs
Time frame: between baseline and day 7
amount of sedative drugs received daily living
Time frame: between baseline and day 7
number of days alive without vasoactive drugs
Time frame: day 28
total amount of vasoactive drugs
Time frame: between baseline and day 7
amount of vasoactive drugs received daily living
Time frame: between baseline and day 7
Number of patients with a pneumothorax
Time frame: day 28
Duration of mechanical ventilation
Time frame: day 60
Duration of stay in ICU
Time frame: day 60
Changes in serum levels of proinflammatory cytokines
Time frame: Hour 1 and Hour 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Derived from this study: PubMed 39287651Richard JM, Beloncle FM, Beduneau G, Mortaza S, Ehrmann S, Diehl JL, Prat G, Jaber S, Rahmani H, Reignier J, Boulain T, Yonis H, Richecoeur J, Thille AW, Declercq PL, Antok E, Carteaux G, Vielle B, Brochard L, Mercat A; REVA network. Pressure control plus spontaneous ventilation versus volume assist-control ventilation in acute respiratory distress syndrome. A randomised clinical trial. Intensive Care Med. 2024 Oct;50(10):1647-1656. doi: 10.1007/s00134-024-07612-3. Epub 2024 Sep 17.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APRV and arterial blood gas measurement each morning in people with Acute Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause hospital mortality (time frame: hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.