ARDSNCT01742715
Three Methods for Best PEEP Determination Compared With PEEP Determination Guided by Adult Respiratory Distress Syndrome (ARDS) Network
A study testing PEEP by Best oxygenation, PEEP by Best Compliance and PEEP by Esophageal pressure in people with ARDS, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS network algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- PEEP by Best oxygenation, PEEP by Best Compliance and PEEP by Esophageal pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 Man and women older than 18 years will be recruited. Patients with acute respiratory failure of any cause who are mechanically ventilated according to the ARDS network recommendations will be considered for inclusion to the study.
- To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of 25 to 30 cmH2O) has to be present, and at least one of the following four severity inclusion criteria has to be met.
- 1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - PaO2 /FIO2 ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain arterial oxygen saturation (SaO2) of > 90%.
- 4 - carbon dioxide partial pressure (PCO2) over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.
Who cannot join
- Patients with any of the following will be excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoscoliosis.
Trial locations and contacts
1 site in 1 country.
Israel1 site
E. Wolfson MC
Holon, 58100
Arie Soroksky, M.D., 972-3-5028770, soroksky@gmail.com
About this study
Official title: Three Methods for Best PEEP Determination Compared With PEEP Determination Guided by Adult Respiratory Distress Syndrome (ARDS) Network, a Crossover Study.
To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS network algorithm.
Read the detailed description
The determination of optimal level of Positive End Expiratory Pressure (PEEP) in patients with acute hypoxemic respiratory pressure remains elusive and controversial.
Several approaches with different algorithms exist. Among them, Low PEEP algorithm approach and High PEEP algorithm approach. These approaches are characterized by a generalized application of certain level of PEEP according to a predefined algorithm. However, these algorithms fail to account for inter-individual variations between patients with different diseases and with different severities of the same underlying process. Therefore, we advocate for an individualized application of PEEP. Whereby, PEEP will be determined individually for each patient based on familiar and well established physiological parameters.
- Conditions
- ARDS
- Being tested
- PEEP by Best oxygenation, PEEP by Best Compliance, PEEP by Esophageal pressure
- Keywords
- ARDS, Lung compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP by Best oxygenationOther
Also called PEEP determined by Best oxygenation approach.
Set PEEP at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg (IBW). FiO2 is set to 60%.
Then decrease PEEP in steps of 4 cmH2O every 10 min until PEEP of 5 cm H2O is reached. In each step static compliance of respiratory system and lung compliance will be measured along with ABGs, and hemodynamic parameters such as cardiac output and mixed venous O2 saturation. Best or optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected.
PEEP by Best ComplianceOther
In this group assessment begins with measuring intrinsic PEEP by an expiratory hold. Thereafter, plateau pressures will be recorded after a 0.5-sec inspiratory pause.
Applied PEEP will be increased by steps of 4 cm H2O, after each incremental step the patient will be observed for 10 minutes to allow for lung unit recruitment and equilibration. Plateau pressure will be measured after each incremental step of PEEP. Applied PEEP will be increased sequentially by 4 cm H2O increments until peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension or decrease of 20% in cardiac output is observed.
PEEP by Esophageal pressureOther
Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiratory pressure of not more than 5 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| PEEP by Best oxygenation | Experimental | Set Positive End Expiratory Pressure (PEEP) at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg Ideal Body Weight (IBW). fraction of inspired oxygen (FiO2) is set to 60%.
Then decrease PEEP in steps of 4 cmH2O every 10 min until PEEP of 5 cm H2O is reached. In each step static compliance of respiratory system and lung compliance will be measured along with arterial blood gas (ABGs), and hemodynamic parameters such as cardiac output and mixed venous O2 saturation. Best or optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% Partial Oxygen tension (PaO2) PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected. Receives: Other: PEEP by Best oxygenation; Other: PEEP by Best Compliance; Other: PEEP by Esophageal pressure |
| PEEP by Best Compliance | Experimental | In this group assessment begins with measuring intrinsic PEEP by an expiratory hold. Thereafter, plateau pressures will be recorded after a 0.5-sec inspiratory pause.
Applied PEEP will be increased by steps of 4 cm H2O, after each incremental step the patient will be observed for 10 minutes to allow for lung unit recruitment and equilibration. Plateau pressure will be measured after each incremental step of PEEP. Applied PEEP will be increased sequentially by 4 cm H2O increments until peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension or decrease of 20% in cardiac output is observed. Receives: Other: PEEP by Best oxygenation; Other: PEEP by Best Compliance; Other: PEEP by Esophageal pressure |
| PEEP by Esophageal pressure | Experimental | Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiratory pressure of not more than 5 cm H2O. Receives: Other: PEEP by Best oxygenation; Other: PEEP by Best Compliance; Other: PEEP by Esophageal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio)
oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio)
Measured: 2 hours
Secondary outcomes (1)
Lung compliance (defined by Tidal Volume divided by Inspiratory transpulmonary pressure)
Lung compliance (defined by Tidal Volume divided by Inspiratory transpulmonary pressure)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arie Soroksky, M.D., Principal investigator, Wolfson MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742715
- Sponsor's protocol ID
- 0156-12-WOMC
- Status last verified
- Oct 2012
- First submitted
- 27 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Methods for Best PEEP Determination Compared With PEEP Determination Guided by Adult Respiratory Distress Syndrome (ARDS) Network, a Crossover Study.
- ClinicalTrials.gov ID
- NCT01742715
- Acronym / sponsor ID
- 0156-12-WOMC
- Conditions
- ARDS
- Keywords
- ARDS, Lung compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Dec 2012 (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.
To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS network algorithm.
Detailed description
The determination of optimal level of Positive End Expiratory Pressure (PEEP) in patients with acute hypoxemic respiratory pressure remains elusive and controversial.
Several approaches with different algorithms exist. Among them, Low PEEP algorithm approach and High PEEP algorithm approach. These approaches are characterized by a generalized application of certain level of PEEP according to a predefined algorithm. However, these algorithms fail to account for inter-individual variations between patients with different diseases and with different severities of the same underlying process. Therefore, we advocate for an individualized application of PEEP. Whereby, PEEP will be determined individually for each patient based on familiar and well established physiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEP by Best oxygenation | Experimental | Other: PEEP by Best oxygenation, Other: PEEP by Best Compliance, Other: PEEP by Esophageal pressureSet Positive End Expiratory Pressure (PEEP) at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg Ideal Body Weight (IBW). fraction of inspired oxygen (FiO2) is set to 60%. Then decrease PEEP in steps of 4 cmH2O every 10 min until PEEP of 5 cm H2O is reached. In each step static compliance of respiratory system and lung compliance will be measured along with arterial blood gas (ABGs), and hemodynamic parameters such as cardiac output and mixed venous O2 saturation. Best or optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% Partial Oxygen tension (PaO2) PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected. |
| PEEP by Best Compliance | Experimental | Other: PEEP by Best oxygenation, Other: PEEP by Best Compliance, Other: PEEP by Esophageal pressureIn this group assessment begins with measuring intrinsic PEEP by an expiratory hold. Thereafter, plateau pressures will be recorded after a 0.5-sec inspiratory pause. Applied PEEP will be increased by steps of 4 cm H2O, after each incremental step the patient will be observed for 10 minutes to allow for lung unit recruitment and equilibration. Plateau pressure will be measured after each incremental step of PEEP. Applied PEEP will be increased sequentially by 4 cm H2O increments until peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension or decrease of 20% in cardiac output is observed. |
| PEEP by Esophageal pressure | Experimental | Other: PEEP by Best oxygenation, Other: PEEP by Best Compliance, Other: PEEP by Esophageal pressureUpon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiratory pressure of not more than 5 cm H2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 Man and women older than 18 years will be recruited. Patients with acute respiratory failure of any cause who are mechanically ventilated according to the ARDS network recommendations will be considered for inclusion to the study.
- To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of 25 to 30 cmH2O) has to be present, and at least one of the following four severity inclusion criteria has to be met.
- 1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - PaO2 /FIO2 ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain arterial oxygen saturation (SaO2) of > 90%.
- 4 - carbon dioxide partial pressure (PCO2) over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.
Key exclusion criteria (1 listed)
- Patients with any of the following will be excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoscoliosis.
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 |
|---|---|---|
| PEEP by Best oxygenationAlso: PEEP determined by Best oxygenation approach.Set PEEP at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg (IBW). FiO2 is set to 60%. Then decrease PEEP in steps of 4 cmH2O every 10 min until PEEP of 5 cm H2O is reached. In each step static compliance of respiratory system and lung compliance will be measured along with ABGs, and hemodynamic parameters such as cardiac output and mixed venous O2 saturation. Best or optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected. | Other | PEEP by Best Compliance, PEEP by Best oxygenation, PEEP by Esophageal pressure |
| PEEP by Best ComplianceIn this group assessment begins with measuring intrinsic PEEP by an expiratory hold. Thereafter, plateau pressures will be recorded after a 0.5-sec inspiratory pause. Applied PEEP will be increased by steps of 4 cm H2O, after each incremental step the patient will be observed for 10 minutes to allow for lung unit recruitment and equilibration. Plateau pressure will be measured after each incremental step of PEEP. Applied PEEP will be increased sequentially by 4 cm H2O increments until peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension or decrease of 20% in cardiac output is observed. | Other | PEEP by Best Compliance, PEEP by Best oxygenation, PEEP by Esophageal pressure |
| PEEP by Esophageal pressureUpon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiratory pressure of not more than 5 cm H2O. | Other | PEEP by Best Compliance, PEEP by Best oxygenation, PEEP by Esophageal pressure |
Primary outcome
Oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio)
Time frame: 2 hours
oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio)
1 secondary outcome
Lung compliance (defined by Tidal Volume divided by Inspiratory transpulmonary pressure)
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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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.
Arie Soroksky, M.D. principal investigator
Wolfson MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP by Best oxygenation, PEEP by Best Compliance and PEEP by Esophageal pressure in people with ARDS, run by Wolfson Medical Center at 1 site in Israel.
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 4 inclusion and 1 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 5 Dec 2012. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2012.