Respiratory Distress Syndrome, AdultNCT00431158
ARDSnet Protocol vs. Open Lung Approach in ARDS
A study testing Different Mechanical Ventilation Protocols in people with Respiratory Distress Syndrome, Adult, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Different Mechanical Ventilation Protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated and mechanically ventilated
- Diagnosis of ARDS using American-European consensus criteria
- Enrollment in study < 48 hours since diagnosis of ARDS
- For 12-36 hrs. (ideally 12-24 hrs) after diagnosis of ARDS, patient must be ventilated as follows: Volume A/C, Tidal volume of 4-8 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, PEEP/FIO2 adjustments using ARDSnet table, Ventilator rate to keep PaCO2 = 35-60 mmHg
- During the 12-36 hour(ideally 12-24 hr) period, PaO2/FIO2 must remain < 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: Volume A/C, Tidal volume = 6 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, Inspiratory time ≤ 1 second, PEEP ≥ 10 cmH2O, FIO2 ≥ 0.5, Ventilator rate to keep PaCO2 = 35-60 mmHg
- No lung recruitment maneuvers or adjunct therapy.
- Total time on mechanical ventilation < 96 hrs. at time of randomization.
Who cannot join
- Age < 18 years or > 80 years
- Weight < 35 kg PBW
- Body mass index > 60
- Intubated 2° to acute exacerbation of a chronic pulmonary disease
- Acute brain injury (ICP > 18 mmHg)
- Immunosuppression 2° to chemo- or radiation therapy
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- Severe cardiac disease(one of the following): New York Heart Association Class 3 or 4, acute coronary syndrome or persistent ventricular tachyarrhythmias
- Positive laboratory pregnancy test
- Sickle cell disease
- Neuromuscular disease
- High risk of mortality within 3 months from cause other than ARDS, e.g. cancer
- More than 2 organ failures (not including pulmonary system)
- Documented lung barotrauma, i.e. chest tube placement other than for fluid drainage
- Persistent hemodynamic instability or intractable shock
- Penetrating chest trauma
- Enrollment in another interventional study
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.
Read the detailed description
The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed according to PEEP and FIO2 relationships as defined in a table. This study compares the ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that prevents recollapse of recruited lung units. The best PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal volumes and plateau pressures.
Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with control of transpulmonary pressure through lower plateau pressures would maximize homogeneity within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving ventilation and outcome in mechanically ventilated ARDS patients.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Different Mechanical Ventilation Protocols
- Keywords
- Acute Respiratory Distress Syndrome, ARDS, Respiratory failure, Mechanical Ventilation, Positive end expiratory pressure, Lung recruitment maneuver
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different Mechanical Ventilation ProtocolsOther
OLA Group: Open lung approach protocol and recruitment maneuvers
ARDSnet Group: ARDSnet protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ARDSnet Protocol Receives: Other: Different Mechanical Ventilation Protocols |
| 2 | Active comparator | OLA Protocol Receives: Other: Different Mechanical Ventilation Protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
60 day mortality
Measured: 60 days
Secondary outcomes (15)
ICU mortality
Measured: Duration of ICU stay
Hospital mortality
Measured: Duration of hospital stay
28 day mortality
Measured: 28 days
180 day mortality
Measured: 180 days
365 day mortality
Measured: 365 days
Ventilator free days
Measured: Hospital stay
Length of ICU stay
Measured: Duration of ICU stay
Development of extra-pulmonary organ failures
Measured: Duration of hospital stay
Duration of hospitalization
Measured: Duration of hospital stay
Incidence of barotrauma
Measured: Duration of hospital stay
Systemic inflammatory mediator levels
Measured: Duration of hospital stay
Lung function 6 months after discharge
Measured: 6 months
Lung function 12 months after discharge
Measured: 12 months
Need for rescue therapy
Measured: Duration of hospital stay
Ventilation associated pneumonia rate
Measured: Duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2012
- Study completionMar 2013
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 Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Robert M Kacmarek, Ph.D., R.R.T, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431158
- Sponsor's protocol ID
- 2006-P-001878
- Other IDs
- BWH IRB Assurance #FWA00000484
- Status last verified
- Sep 2014
- First submitted
- 1 Feb 2007
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
PubMed 26672923
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00431158
- Acronym / sponsor ID
- 2006-P-001878
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute Respiratory Distress Syndrome, ARDS, Respiratory failure, Mechanical Ventilation, Positive end expiratory pressure, Lung recruitment maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Feb 2007 (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.
Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.
Detailed description
The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed according to PEEP and FIO2 relationships as defined in a table. This study compares the ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that prevents recollapse of recruited lung units. The best PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal volumes and plateau pressures.
Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with control of transpulmonary pressure through lower plateau pressures would maximize homogeneity within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving ventilation and outcome in mechanically ventilated ARDS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Different Mechanical Ventilation ProtocolsARDSnet Protocol |
| 2 | Active comparator | Other: Different Mechanical Ventilation ProtocolsOLA Protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Intubated and mechanically ventilated
- Diagnosis of ARDS using American-European consensus criteria
- Enrollment in study < 48 hours since diagnosis of ARDS
- For 12-36 hrs. (ideally 12-24 hrs) after diagnosis of ARDS, patient must be ventilated as follows: Volume A/C, Tidal volume of 4-8 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, PEEP/FIO2 adjustments using ARDSnet table, Ventilator rate to keep PaCO2 = 35-60 mmHg
- During the 12-36 hour(ideally 12-24 hr) period, PaO2/FIO2 must remain < 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: Volume A/C, Tidal volume = 6 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, Inspiratory time ≤ 1 second, PEEP ≥ 10 cmH2O, FIO2 ≥ 0.5, Ventilator rate to keep PaCO2 = 35-60 mmHg
Key exclusion criteria (16 listed)
- Age < 18 years or > 80 years
- Weight < 35 kg PBW
- Body mass index > 60
- Intubated 2° to acute exacerbation of a chronic pulmonary disease
- Acute brain injury (ICP > 18 mmHg)
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 |
|---|---|---|
| Different Mechanical Ventilation ProtocolsOLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol | Other | 1, 2 |
Primary outcome
60 day mortality
Time frame: 60 days
15 secondary outcomes
ICU mortality
Time frame: Duration of ICU stay
Hospital mortality
Time frame: Duration of hospital stay
28 day mortality
Time frame: 28 days
180 day mortality
Time frame: 180 days
365 day mortality
Time frame: 365 days
Ventilator free days
Time frame: Hospital stay
Length of ICU stay
Time frame: Duration of ICU stay
Development of extra-pulmonary organ failures
Time frame: Duration of hospital stay
Duration of hospitalization
Time frame: Duration of hospital stay
Incidence of barotrauma
Time frame: Duration of hospital stay
Systemic inflammatory mediator levels
Time frame: Duration of hospital stay
Lung function 6 months after discharge
Time frame: 6 months
Lung function 12 months after discharge
Time frame: 12 months
Need for rescue therapy
Time frame: Duration of hospital stay
Ventilation associated pneumonia rate
Time frame: Duration of hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Derived from this study: PubMed 26672923Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
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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.
Robert M Kacmarek, Ph.D., R.R.T principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different Mechanical Ventilation Protocols in people with Respiratory Distress Syndrome, Adult, run by Massachusetts General Hospital at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 18 Sep 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
60 day mortality (time frame: 60 days). 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 NCT00431158, 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 18 Sep 2014.