Positive Expiratory PressureDROPNCT03969407
Determination of the Best Positive End-expiratory Pressure (PEEP)
An observational study of Positive Expiratory Pressure and Acute Respiratory Distress Syndrome, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome (ARDS) after cardiothoracic surgery The use of a positive end-expiratory pressure in acute respiratory distress syndrome is obvious in ARDS management. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Positive Expiratory Pressure, Acute Respiratory Distress Syndrome
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2018to 20 Jul 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient admitted to adult intensive care with ARDS following cardiothoracic surgery.
Who may be able to join
- All Patients admitted for intensive care with acute respiratory distress syndrome intubated according to the criteria of the Berlin Consensus
Who cannot join
- Undrained pneumothoraces
- Hemodynamic instability defined by increased need of vasopressors and / or an systolic arterial pressure below 90 mmHg
- Hypovolemic shock
- Bronchopleural fistula
- High intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Best Positive End-expiratory Pressure (PEEP) Based on Oxygenation or Driving Pressure in Patients With Acute Respiratory Distress Syndrome After Cardiac Thoracic Surgery
Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome (ARDS) after cardiothoracic surgery
The use of a positive end-expiratory pressure in acute respiratory distress syndrome is obvious in ARDS management. On the one hand it serves to fight against the reduction of functional residual capacity (FRC) and enable the limitation of hypoxia; and on the other hand it allows the limitation of "opening/closing" lesions in pulmonary alveoli which lead to increase "bio trauma".
Read more
However elevated PEEP has harmful effect such as hemodynamic effect on the right ventricle and distension on healthy part of the lung.Other adverse effects are: decreasing cardiac output, increased risk of barotrauma, and the interference with assessment of hemodynamic pressures.
Ideally the adjustment of PEEP level must be done by taking into account each patient characteristic. PEEP titration based on blood gas analysis is one of the most used techniques by physicians.
Current guidelines for lung-protective ventilation in patients with acute respiratory distress syndrome (ARDS) suggest the use of low tidal volumes (Vt), set according to ideal body weight (IBW) of the patient, and higher levels of positive end-expiratory pressure (PEEP) to limit ventilator-induced lung injury (VILI). However, recent studies have shown that ARDS patients who are ventilated according to these guidelines may still be exposed to forces that can induce or aggravate lung injury.
Driving pressure (DP) is the difference between the airway pressure at the end of inspiration (plateau pressure, Ppl) and PEEP.
Driving pressure may be a valuable tool to set PEEP. Independent of the strategy used to titrate PEEP, changes in PEEP levels should consider the impact on driving pressure, besides other variables such as gas exchange and hemodynamics. A decrease in driving pressure after increasing PEEP will necessarily reflect recruitment and a decrease in cyclic strain. On the contrary, an increase in driving pressure will suggest a non-recruitable lung, in which overdistension prevails over recruitment.
The main purposes of this study are to assess the optimal PEEP based on the best driving pressure or the best oxygenation.
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Best PEEP level based on the best driving pressure value
Measured: 1 DAY
Best PEEP level based on the best oxygenation value defined by the PaO2/FiO2 ratio.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start20 Nov 2018
- Primary completion20 Jun 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive Expiratory PressureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969407
- Sponsor's protocol ID
- 2018-A01760-55
- Acronym
- DROP
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Best Positive End-expiratory Pressure (PEEP) Based on Oxygenation or Driving Pressure in Patients With Acute Respiratory Distress Syndrome After Cardiac Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03969407
- Acronym / sponsor ID
- DROP / 2018-A01760-55
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 31 May 2019 (actual)
- 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.
Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome (ARDS) after cardiothoracic surgery
The use of a positive end-expiratory pressure in acute respiratory distress syndrome is obvious in ARDS management. On the one hand it serves to fight against the reduction of functional residual capacity (FRC) and enable the limitation of hypoxia; and on the other hand it allows the limitation of "opening/closing" lesions in pulmonary alveoli which lead to increase "bio trauma".
However elevated PEEP has harmful effect such as hemodynamic effect on the right ventricle and distension on healthy part of the lung.Other adverse effects are: decreasing cardiac output, increased risk of barotrauma, and the interference with assessment of hemodynamic pressures.
Ideally the adjustment of PEEP level must be done by taking into account each patient characteristic. PEEP titration based on blood gas analysis is one of the most used techniques by physicians.
Current guidelines for lung-protective ventilation in patients with acute respiratory distress syndrome (ARDS) suggest the use of low tidal volumes (Vt), set according to ideal body weight (IBW) of the patient, and higher levels of positive end-expiratory pressure (PEEP) to limit ventilator-induced lung injury (VILI). However, recent studies have shown that ARDS patients who are ventilated according to these guidelines may still be exposed to forces that can induce or aggravate lung injury.
Driving pressure (DP) is the difference between the airway pressure at the end of inspiration (plateau pressure, Ppl) and PEEP.
Driving pressure may be a valuable tool to set PEEP. Independent of the strategy used to titrate PEEP, changes in PEEP levels should consider the impact on driving pressure, besides other variables such as gas exchange and hemodynamics. A decrease in driving pressure after increasing PEEP will necessarily reflect recruitment and a decrease in cyclic strain. On the contrary, an increase in driving pressure will suggest a non-recruitable lung, in which overdistension prevails over recruitment.
The main purposes of this study are to assess the optimal PEEP based on the best driving pressure or the best oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient admitted to adult intensive care with ARDS following cardiothoracic surgery.
Key inclusion criteria (1 listed)
- All Patients admitted for intensive care with acute respiratory distress syndrome intubated according to the criteria of the Berlin Consensus
Key exclusion criteria (5 listed)
- Undrained pneumothoraces
- Hemodynamic instability defined by increased need of vasopressors and / or an systolic arterial pressure below 90 mmHg
- Hypovolemic shock
- Bronchopleural fistula
- High intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best PEEP level based on the best driving pressure value
Time frame: 1 DAY
Best PEEP level based on the best oxygenation value defined by the PaO2/FiO2 ratio.
Time frame: 1 DAY
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 23 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Positive Expiratory Pressure
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Congenital Heart Disease, Cardiopulmonary Bypass
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?
An observational study of Positive Expiratory Pressure and Acute Respiratory Distress Syndrome, run by Centre Chirurgical Marie Lannelongue 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 1 inclusion and 5 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 23 Jan 2020. 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?
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?
Best PEEP level based on the best driving pressure value (time frame: 1 DAY). The study lists 2 primary outcomes in all. 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 23 Jan 2020.