Acute Respiratory Failure With HypoxiaNCT04912960
PEEP in Patients With Acute Respiratory Failure
An observational study of Acute Respiratory Failure With Hypoxia, run by Jesus Villar at 3 sites in Spain.
Trial summary
Positive end-expiratory pressure (PEEP) has become an essential component of the care of critically ill patients who require ventilatory support. In 1975, several investigators published the effects of PEEP in 15 mechanically ventilated patients with acute respiratory failure (ARF) supported by mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesSpain
- Study dates
- 10 Jun 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Mechanically ventilated patients with hypoxemic respiratory failure (PaO2/FiO2 <300 on FiO2 equal or greater than 0.3)
Who may be able to join
- Intubated patients requiring MV for >24 h
- Age >18 years
- Acute hypoxemic respiratory failure, defined as a PaO2/FiO2 <300 with an FiO2 ≥0.3 and PEEP≥5 cmH2O.
- ARF caused by pulmonary insults.
Who cannot join
- ARF from non-pulmonary origin.
- Contraindications from high PEEP (severe head trauma or severe chest trauma).
- Patients that cannot maintained supine position.
- Uncorrected hypovolemia
- Hemodynamic instability
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Clinic
Barcelona
Carlos Ferrando, MD, PhD, +34609892732, cafeoranestesia@gmail.com
- Recruiting
Hospital Universitario Dr. Negrin
Las Palmas de Gran Canaria, Las Palmas, 35019
Jesús Villar, MD, PhD, +34606860027, jesus.villar54@gmail.com
Angel Becerra, MD, +34676229025, ang_bcr.bol@hotmail.com
- Not yet recruiting
Hospital Universitario La Princesa
Madrid
Fernando Suárez-Sipmann, MD, PhD, fsuarezsipmann@gmail.com
About this study
Official title: Application of PEEP in Patients With Acute Respiratory Failure Caused by Lung Injury: Assessment of Clinical Practice
Positive end-expiratory pressure (PEEP) has become an essential component of the care of critically ill patients who require ventilatory support. In 1975, several investigators published the effects of PEEP in 15 mechanically ventilated patients with acute respiratory failure (ARF) supported by mechanical ventilation. FiO2 ranged between 21% to 75% and the tidal volume between 13 to 15 mL/kg. PEEP was increased in 3 cmH2O steps until cardiac output fell. The aim was to identify the "optimum" PEEP level. "Best" PEEP was associated simultaneously with the best static compliance of the respiratory system, the greatest oxygen transport, and the lowest dead space fraction. That study established the basis for the use of PEEP in patients with ARF worldwide. Although currently patients with ARF are ventilated with much lower tidal volumes, that study has never been validated. It is unknow whether their findings are currently valid, generalizable, and reproducible.
Read the detailed description
With the application of PEEP, the baseline end-expiratory pressure in mechanically ventilated patients is elevated above atmospheric pressure. PEEP is applied generally to improve oxygenation, which is usually not observed unless there is a concomitant increase in the functional residual capacity, probably by preventing airway closure and recruiting previously unventilated alveoli.
Fifty years later, we have improved our knowledge on lung physiology and pulmonary mechanics in patients requiring mechanical ventilation (MV). To date, most ARF patients on MV are managed with incremental PEEP levels.
The team of investigators in this study has postulated that it is appropriate to assess whether the routine clinical practice of applying increasing levels of PEEP pursues the best oxygenation and the best compliance, or by contrary, it was a random finding by investigators back in 1975. For the current assessment of this approach at the bedside (gradual increase of PEEP to identify the optimum level of PEEP), the investigators cannot reproduce exactly that approach since current recommendations for ventilating patients with severe ARF include: (i) the use of tidal volumes between 4-8 ml/kg predicted body weight, (ii) monitoring cardiac output using a pulmonary artery catheter is not a routine clinical practice in critically ill patients, and (iii) measuring dead space fraction is not part of the routine management of patients with acute respiratory failure.
The investigators in this study will assess in 15 mechanically ventilated patients with ARF whether the highest lung compliance during the identification of optimal PEEP in each patient coincides with the level of best oxygenation and ventilation. PEEP levels will be individualized in each patient, as part of common practice in the Post-Surgical Critical Care Unit of the hospital. Data from 15 patients requiring MV for >24 h due to ARF will be analyzed to identify the optimum PEEP level. Only data from patients in which the cause of ARF is of pulmonary origin (atelectasis, lung contusion, aspiration of gastric content, and lung infection) will be analyzed.
- Conditions
- Acute Respiratory Failure With Hypoxia
- Being tested
- Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Also called positive end-expiratory pressure
Optimum PEEP
What is being measured
The primary outcome is the main question the study is designed to answer.
static compliance of the respiratory system
ratio of tidal volume to pressure gradiente of the respiratory system
Measured: at study enrollment
oxygen transport
Cardiac output multiply by oxygen content in arterial blood
Measured: at study enrollment
dead space fraction
ratio of dead space to tidal volume
Measured: at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start10 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure With HypoxiaStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesus Villar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jesus Villar, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Jesús Villar, MD, Study director, Hospital Universitario Dr. Negrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912960
- Sponsor's protocol ID
- 170090
- Status last verified
- Apr 2025
- First submitted
- 24 May 2021
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data collection will be shared with all study investigators
Publications
Suter PM, Fairley B, Isenberg MD. Optimum end-expiratory airway pressure in patients with acute pulmonary failure. N Engl J Med. 1975 Feb 6;292(6):284-9. doi: 10.1056/NEJM197502062920604.
PubMed 234174Acute 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 10793162
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of PEEP in Patients With Acute Respiratory Failure Caused by Lung Injury: Assessment of Clinical Practice
- ClinicalTrials.gov ID
- NCT04912960
- Acronym / sponsor ID
- 170090
- Conditions
- Acute Respiratory Failure With Hypoxia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jesus VillarUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2021 (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.
Positive end-expiratory pressure (PEEP) has become an essential component of the care of critically ill patients who require ventilatory support. In 1975, several investigators published the effects of PEEP in 15 mechanically ventilated patients with acute respiratory failure (ARF) supported by mechanical ventilation. FiO2 ranged between 21% to 75% and the tidal volume between 13 to 15 mL/kg. PEEP was increased in 3 cmH2O steps until cardiac output fell. The aim was to identify the "optimum" PEEP level. "Best" PEEP was associated simultaneously with the best static compliance of the respiratory system, the greatest oxygen transport, and the lowest dead space fraction. That study established the basis for the use of PEEP in patients with ARF worldwide. Although currently patients with ARF are ventilated with much lower tidal volumes, that study has never been validated. It is unknow whether their findings are currently valid, generalizable, and reproducible.
Detailed description
With the application of PEEP, the baseline end-expiratory pressure in mechanically ventilated patients is elevated above atmospheric pressure. PEEP is applied generally to improve oxygenation, which is usually not observed unless there is a concomitant increase in the functional residual capacity, probably by preventing airway closure and recruiting previously unventilated alveoli.
Fifty years later, we have improved our knowledge on lung physiology and pulmonary mechanics in patients requiring mechanical ventilation (MV). To date, most ARF patients on MV are managed with incremental PEEP levels.
The team of investigators in this study has postulated that it is appropriate to assess whether the routine clinical practice of applying increasing levels of PEEP pursues the best oxygenation and the best compliance, or by contrary, it was a random finding by investigators back in 1975. For the current assessment of this approach at the bedside (gradual increase of PEEP to identify the optimum level of PEEP), the investigators cannot reproduce exactly that approach since current recommendations for ventilating patients with severe ARF include: (i) the use of tidal volumes between 4-8 ml/kg predicted body weight, (ii) monitoring cardiac output using a pulmonary artery catheter is not a routine clinical practice in critically ill patients, and (iii) measuring dead space fraction is not part of the routine management of patients with acute respiratory failure.
The investigators in this study will assess in 15 mechanically ventilated patients with ARF whether the highest lung compliance during the identification of optimal PEEP in each patient coincides with the level of best oxygenation and ventilation. PEEP levels will be individualized in each patient, as part of common practice in the Post-Surgical Critical Care Unit of the hospital. Data from 15 patients requiring MV for >24 h due to ARF will be analyzed to identify the optimum PEEP level. Only data from patients in which the cause of ARF is of pulmonary origin (atelectasis, lung contusion, aspiration of gastric content, and lung infection) will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients with hypoxemic respiratory failure (PaO2/FiO2 <300 on FiO2 equal or greater than 0.3)
Key inclusion criteria (4 listed)
- Intubated patients requiring MV for >24 h
- Age >18 years
- Acute hypoxemic respiratory failure, defined as a PaO2/FiO2 <300 with an FiO2 ≥0.3 and PEEP≥5 cmH2O.
- ARF caused by pulmonary insults.
Key exclusion criteria (5 listed)
- ARF from non-pulmonary origin.
- Contraindications from high PEEP (severe head trauma or severe chest trauma).
- Patients that cannot maintained supine position.
- Uncorrected hypovolemia
- Hemodynamic instability
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 |
|---|---|---|
| Mechanical ventilationAlso: positive end-expiratory pressureOptimum PEEP | Device | – |
Primary outcome
static compliance of the respiratory system
Time frame: at study enrollment
ratio of tidal volume to pressure gradiente of the respiratory system
oxygen transport
Time frame: at study enrollment
Cardiac output multiply by oxygen content in arterial blood
dead space fraction
Time frame: at study enrollment
ratio of dead space to tidal volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Background: PubMed 234174Suter PM, Fairley B, Isenberg MD. Optimum end-expiratory airway pressure in patients with acute pulmonary failure. N Engl J Med. 1975 Feb 6;292(6):284-9. doi: 10.1056/NEJM197502062920604.
- 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.
- Individual participant dataSharing planned: No. data collection will be shared with all study investigators
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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.
Jesús Villar, MD study director
Hospital Universitario Dr. Negrin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure With Hypoxia, run by Jesus Villar at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesús Villar, MD (+34606860027, jesus.villar54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static compliance of the respiratory system (time frame: at study enrollment). The study lists 3 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 NCT04912960, which also lists 2 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 20 Apr 2025.