Respiratory Distress Syndrome, AdultNCT00236262
Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
A study testing ventilatory strategies with pressure in people with Respiratory Distress Syndrome, Adult, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate pressure among patients with syndrome of acute respiratory distress of the adult (SDRA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- ventilatory strategies with pressure
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2005to Sep 2006
- 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
- Intubation and artificial ventilation
- Bilateral pulmonary opacities radiological compatible with an organic pulmonary oedema
- PaO2/FiO2 report/ratio < 200 mmHg
- Not obviously clinical or echocardiographic of rise in the pressure of ventricular filling left
- Joint presence of criteria 2, 3 and 4 since less than 72 hours
Who cannot join
- Age <18 years
- Pregnancy
- Obstructive chronic broncho-pneumonopathy
- Suspected or confirmed intracranial hypertension
- Pneumothorax
- Evolutionary oesophageal pathology
Show all 9Show fewer
- Hemodynamic instability with need of filling vascular or modification of posology of the vasopressors in the 2 hours preceding inclusion
- PaO2/FiO2 Report/ratio < 50 mmHg
- Amount of adrenaline or noradrenaline higher than 2 mg/hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Positive Expiratory Pressure on the Right Ventricular Function in Patient With Adult Respiratory Distress Syndrome Ventilated With Limited Plateau Pressure
The objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate pressure among patients with syndrome of acute respiratory distress of the adult (SDRA). The assumption tested is that a high level of PEP increases the impedance with the ejection of the right ventricle independently of the level of plate pressure. The effect on the right ventricular preload will be checked via the analysis of the respiratory variability of the diameter of the higher vena cava.
Read the detailed description
Background: The ventilatory strategy in patients with Adult Respiratory Distress Syndrome (ARDS) is still controversial concerning the finest level of positive expiratory pressure (PEP). In fact, PEP allows optimisation of lung recruitment and oxygenation. However, high PEP may be detrimental on hemodynamics, notably impairing filling and ejection of the right ventricle (RV). At present, it is not known whether these adverse effects of PEP are independent or not of plateau pressure.
Objectives: The aim of the present study is to explore the effect of PEP variations (with constant plateau pressure) on RV function (assessed using trans-oesophageal echocardiography, TOE) in patients with ARDS. The assumption tested is that a high level of PEP increases the impedance to RV ejection independently of the level of plateau pressure. The effect of PEP on the right ventricular preload will also be checked via the analysis of the respiratory variability of the diameter of superior vena cava. Respiratory system properties will be assessed as follows: alveolar dead space determination using expired CO2, alveolar recruitment calculation using pressure-volume curves.
Methods: The patients are ventilated according to three consecutive strategies (A, B and C), using the same plateau pressure (<30 cm H2O), but different PEP levels: low PEP in strategy A and high PEP in strategies B and C. In order to maintain a constant plateau pressure, the increase in PEP level in strategies B and C is accompanied by a decrease in tidal volume. This decrease in tidal volume is compensated by an increase in respiratory frequency (strategy B) or a decrease of instrumental dead space by removal of heat and moisture exchanger filter (strategy C).
The first ventilatory strategy tested is "A". After that, the patient is randomised for strategies "B then C", or "C then B". At the end of each strategies the following explorations are performed: TOE, respiratory system pressure-volume curves, expired CO2 analysis, and arterial blood gas analysis.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- ventilatory strategies with pressure
- Keywords
- SDRA, Distress, Expiratory, Pressure, Ventilatory
- 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.
ventilatory strategies with pressureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Assistance Publique - Hôpitaux de ParisThe 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
- Single group
- Masking
- Single blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Laurent BROCHARD, Pr,MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236262
- Sponsor's protocol ID
- P040202
- Other IDs
- PS040202
- Status last verified
- Mar 2007
- First submitted
- 7 Oct 2005
- Last updated
- 26 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bouadma L, Lellouche F, Cabello B, Taille S, Mancebo J, Dojat M, Brochard L. Computer-driven management of prolonged mechanical ventilation and weaning: a pilot study. Intensive Care Med. 2005 Oct;31(10):1446-50. doi: 10.1007/s00134-005-2766-2. Epub 2005 Aug 23.
PubMed 16132889Lacherade JC, Auburtin M, Cerf C, Van de Louw A, Soufir L, Rebufat Y, Rezaiguia S, Ricard JD, Lellouche F, Brun-Buisson C, Brochard L. Impact of humidification systems on ventilator-associated pneumonia: a randomized multicenter trial. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1276-82. doi: 10.1164/rccm.200408-1028OC. Epub 2005 Aug 26.
PubMed 16126933Mekontso Dessap A, Charron C, Devaquet J, Aboab J, Jardin F, Brochard L, Vieillard-Baron A. Impact of acute hypercapnia and augmented positive end-expiratory pressure on right ventricle function in severe acute respiratory distress syndrome. Intensive Care Med. 2009 Nov;35(11):1850-8. doi: 10.1007/s00134-009-1569-2. Epub 2009 Aug 4.
PubMed 19652953
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Positive Expiratory Pressure on the Right Ventricular Function in Patient With Adult Respiratory Distress Syndrome Ventilated With Limited Plateau Pressure
- ClinicalTrials.gov ID
- NCT00236262
- Acronym / sponsor ID
- P040202
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- SDRA, Distress, Expiratory, Pressure, Ventilatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 12 Oct 2005 (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 objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate pressure among patients with syndrome of acute respiratory distress of the adult (SDRA). The assumption tested is that a high level of PEP increases the impedance with the ejection of the right ventricle independently of the level of plate pressure. The effect on the right ventricular preload will be checked via the analysis of the respiratory variability of the diameter of the higher vena cava.
Detailed description
Background: The ventilatory strategy in patients with Adult Respiratory Distress Syndrome (ARDS) is still controversial concerning the finest level of positive expiratory pressure (PEP). In fact, PEP allows optimisation of lung recruitment and oxygenation. However, high PEP may be detrimental on hemodynamics, notably impairing filling and ejection of the right ventricle (RV). At present, it is not known whether these adverse effects of PEP are independent or not of plateau pressure.
Objectives: The aim of the present study is to explore the effect of PEP variations (with constant plateau pressure) on RV function (assessed using trans-oesophageal echocardiography, TOE) in patients with ARDS. The assumption tested is that a high level of PEP increases the impedance to RV ejection independently of the level of plateau pressure. The effect of PEP on the right ventricular preload will also be checked via the analysis of the respiratory variability of the diameter of superior vena cava. Respiratory system properties will be assessed as follows: alveolar dead space determination using expired CO2, alveolar recruitment calculation using pressure-volume curves.
Methods: The patients are ventilated according to three consecutive strategies (A, B and C), using the same plateau pressure (<30 cm H2O), but different PEP levels: low PEP in strategy A and high PEP in strategies B and C. In order to maintain a constant plateau pressure, the increase in PEP level in strategies B and C is accompanied by a decrease in tidal volume. This decrease in tidal volume is compensated by an increase in respiratory frequency (strategy B) or a decrease of instrumental dead space by removal of heat and moisture exchanger filter (strategy C).
The first ventilatory strategy tested is "A". After that, the patient is randomised for strategies "B then C", or "C then B". At the end of each strategies the following explorations are performed: TOE, respiratory system pressure-volume curves, expired CO2 analysis, and arterial blood gas analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intubation and artificial ventilation
- Bilateral pulmonary opacities radiological compatible with an organic pulmonary oedema
- PaO2/FiO2 report/ratio < 200 mmHg
- Not obviously clinical or echocardiographic of rise in the pressure of ventricular filling left
- Joint presence of criteria 2, 3 and 4 since less than 72 hours
Key exclusion criteria (9 listed)
- Age <18 years
- Pregnancy
- Obstructive chronic broncho-pneumonopathy
- Suspected or confirmed intracranial hypertension
- Pneumothorax
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 |
|---|---|---|
| ventilatory strategies with pressure | Device | – |
Primary outcome
Safety
Efficacy
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 26 Mar 2007.
- Background: PubMed 16132889Bouadma L, Lellouche F, Cabello B, Taille S, Mancebo J, Dojat M, Brochard L. Computer-driven management of prolonged mechanical ventilation and weaning: a pilot study. Intensive Care Med. 2005 Oct;31(10):1446-50. doi: 10.1007/s00134-005-2766-2. Epub 2005 Aug 23.
- Background: PubMed 16126933Lacherade JC, Auburtin M, Cerf C, Van de Louw A, Soufir L, Rebufat Y, Rezaiguia S, Ricard JD, Lellouche F, Brun-Buisson C, Brochard L. Impact of humidification systems on ventilator-associated pneumonia: a randomized multicenter trial. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1276-82. doi: 10.1164/rccm.200408-1028OC. Epub 2005 Aug 26.
- Derived from this study: PubMed 19652953Mekontso Dessap A, Charron C, Devaquet J, Aboab J, Jardin F, Brochard L, Vieillard-Baron A. Impact of acute hypercapnia and augmented positive end-expiratory pressure on right ventricle function in severe acute respiratory distress syndrome. Intensive Care Med. 2009 Nov;35(11):1850-8. doi: 10.1007/s00134-009-1569-2. Epub 2009 Aug 4.
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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.
Laurent BROCHARD, Pr,MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilatory strategies with pressure in people with Respiratory Distress Syndrome, Adult, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 9 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 26 Mar 2007. 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?
Safety. 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?
On the ClinicalTrials.gov record for NCT00236262, which also lists 3 linked publications.
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 26 Mar 2007.