Respiratory Distress Syndrome, AdultPEEP-HUPANCT01119872
Pilot Study of Positive-End Expiratory Pressure in Acute Respiratory Distress Syndrome
A study testing Positive End-expiratory Pressure (PEEP) in people with Respiratory Distress Syndrome, Adult, run by Hospital Universitario Principe de Asturias at 1 site in Spain.
Trial summary
Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied… 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?
- Positive End-expiratory Pressure (PEEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2003to Dec 2008
- 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
- Patients with Acute Respiratory Distress Syndrome (ARDS) according to the American-European Consensus Conference definition, after 24 hours under mechanical ventilation.
Who cannot join
- Younger than 18-year-old
- Pregnancy
- Neuromuscular diseases
- Intracranial hypertension. Head trauma
- Left ventricular dysfunction
- Mechanical ventilation for more than 72 hours
Show all 9Show fewer
- Previous barotrauma
- Patients with terminal stage of an illness and high risk of mortality within 90 days
- Patients who refused to consent to the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Critical Care Unit. Universitary Hospital Principe de Asturias
Alcalá de Henares, Madrid, 28805
About this study
Official title: Randomized Controlled Pilot Study of Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome(ARDS): Individualized According to the Best Compliance or Fixed According to Fraction of Inspired Oxygen (FiO2) Applied
Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.
Read the detailed description
In patients with Acute Respiratory Distress Syndrome the use of Positive End-Expiratory Pressure (PEEP) avoids atelectrauma, improves gas exchange and induces alveolar recruitment.Although it has side effects as inducing alveolar overdistension and circulatory depression.
There are several methods to determine the level of PEEP to be applied. We conducted a study to test the hypothesis that an individualized level of PEEP, set et the best compliance, when compared with a fixed level according to the fraction of inspired oxygen applied, improves oxygenation and reduces mortality rate at 28 days.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Positive End-expiratory Pressure (PEEP)
- Keywords
- Positive-Pressure Respiration, Respiration, Artificial
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive End-expiratory Pressure (PEEP)Other
Also called Compliance-guided PEEP group: Grupo meseta, FiO2-driven-PEEP group: Grupo tabla
All patients were ventilated during 24 hours with low tidal volume (6-8 milliliters/kilogram of predicted body weight), plateau airway pressure limited at 35 centimeters of water, initial ventilator rate of 30 breaths/minute adjusted to maintain a pH goal of 7.30 to 7.45 to a maximum of 35 breaths/minute, fraction of inspired oxygen ensuring arterial oxygen saturation 88-95% or arterial partial pressure of oxygen of 55-80 mmHg.
Level of Positive End-Expiratory Pressure (PEEP) applied according the 2 arms of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Compliance-guided PEEP group | Other | Positive End-Expiratory Pressure(PEEP) level was set daily, according to the method described by Suter in 1978. Static compliance (Cst) was calculated at different levels of PEEP at a constant tidal ventilation of 6-8 ml/kg of predicted body weight. Cst was determined by dividing tidal volume by the difference between the pressure at the end of inflation hold and the PEEP. The maximum value of Cst in individual patients was considered as the best PEEP. Receives: Other: Positive End-expiratory Pressure (PEEP) |
| FiO2-driven-PEEP group | Other | PEEP was set based on the patient fraction of inspired oxygen (FiO2) according to the Positive End-Expiratory Pressure(PEEP) strategy reported in 2000:"Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network". Receives: Other: Positive End-expiratory Pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Oxygenation
Evolution of arterial oxygenation during the 28 days after study randomization
Measured: 28 days
Secondary outcomes (3)
Mortality
Mortality 28 days after randomization
Measured: 28 days
Number of ventilator-free days at day 28
Number of ventilator-free days at day 28 after randomization
Measured: 28 days
multivariate analysis of mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startJan 2003
- Primary completionDec 2007
- Study completionDec 2008
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.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Principe de Asturias
- Sponsor type
- University, hospital or other
- Investigators
- María del Consuelo Pintado, MD, PhD, Principal investigator, Critical Care Unit. Universitary Hospital Principe de AsturiasRaúl de Pablo, MD, PhD, Principal investigator, Critical Care Unit. Universitary Hospital Principe de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119872
- Sponsor's protocol ID
- UCI-HUPA-1
- Acronym
- PEEP-HUPA
- Status last verified
- Dec 2002
- First submitted
- 6 May 2010
- Last updated
- 10 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62. doi: 10.1378/chest.73.2.158.
PubMed 340159Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.
PubMed 23362167
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study of Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome(ARDS): Individualized According to the Best Compliance or Fixed According to Fraction of Inspired Oxygen (FiO2) Applied
- ClinicalTrials.gov ID
- NCT01119872
- Acronym / sponsor ID
- PEEP-HUPA / UCI-HUPA-1
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Positive-Pressure Respiration, Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital Universitario Principe de AsturiasUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 May 2010 (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.
Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.
Detailed description
In patients with Acute Respiratory Distress Syndrome the use of Positive End-Expiratory Pressure (PEEP) avoids atelectrauma, improves gas exchange and induces alveolar recruitment.Although it has side effects as inducing alveolar overdistension and circulatory depression.
There are several methods to determine the level of PEEP to be applied. We conducted a study to test the hypothesis that an individualized level of PEEP, set et the best compliance, when compared with a fixed level according to the fraction of inspired oxygen applied, improves oxygenation and reduces mortality rate at 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliance-guided PEEP group | Other | Other: Positive End-expiratory Pressure (PEEP)Positive End-Expiratory Pressure(PEEP) level was set daily, according to the method described by Suter in 1978. Static compliance (Cst) was calculated at different levels of PEEP at a constant tidal ventilation of 6-8 ml/kg of predicted body weight. Cst was determined by dividing tidal volume by the difference between the pressure at the end of inflation hold and the PEEP. The maximum value of Cst in individual patients was considered as the best PEEP. |
| FiO2-driven-PEEP group | Other | Other: Positive End-expiratory Pressure (PEEP)PEEP was set based on the patient fraction of inspired oxygen (FiO2) according to the Positive End-Expiratory Pressure(PEEP) strategy reported in 2000:"Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Acute Respiratory Distress Syndrome (ARDS) according to the American-European Consensus Conference definition, after 24 hours under mechanical ventilation.
Key exclusion criteria (9 listed)
- Younger than 18-year-old
- Pregnancy
- Neuromuscular diseases
- Intracranial hypertension. Head trauma
- Left ventricular dysfunction
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 |
|---|---|---|
| Positive End-expiratory Pressure (PEEP)Also: Compliance-guided PEEP group: Grupo meseta, FiO2-driven-PEEP group: Grupo tablaAll patients were ventilated during 24 hours with low tidal volume (6-8 milliliters/kilogram of predicted body weight), plateau airway pressure limited at 35 centimeters of water, initial ventilator rate of 30 breaths/minute adjusted to maintain a pH goal of 7.30 to 7.45 to a maximum of 35 breaths/minute, fraction of inspired oxygen ensuring arterial oxygen saturation 88-95% or arterial partial pressure of oxygen of 55-80 mmHg. Level of Positive End-Expiratory Pressure (PEEP) applied according the 2 arms of treatment. | Other | Compliance-guided PEEP group, FiO2-driven-PEEP group |
Primary outcome
Arterial Oxygenation
Time frame: 28 days
Evolution of arterial oxygenation during the 28 days after study randomization
3 secondary outcomes
Mortality
Time frame: 28 days
Number of ventilator-free days at day 28
Time frame: 28 days
multivariate analysis of mortality
Time frame: 28 days
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 10 May 2010.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 340159Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62. doi: 10.1378/chest.73.2.158.
- Derived from this study: PubMed 23362167Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.
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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.
María del Consuelo Pintado, MD, PhD principal investigator
Critical Care Unit. Universitary Hospital Principe de Asturias
Raúl de Pablo, MD, PhD principal investigator
Critical Care Unit. Universitary Hospital Principe de Asturias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive End-expiratory Pressure (PEEP) in people with Respiratory Distress Syndrome, Adult, run by Hospital Universitario Principe de Asturias at 1 site in Spain.
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 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 10 May 2010. 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 Spain. 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?
Arterial Oxygenation (time frame: 28 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 NCT01119872, 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 10 May 2010.