PEEP in Patients With Acute Respiratory Failure

NCT ID: NCT04912960

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Acute Respiratory Failure With Hypoxia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mechanical ventilation

Optimum PEEP

Intervention Type: DEVICE

Other Intervention Names

positive end-expiratory pressure

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jesus Villar

OTHER

Sponsor Role: lead

Responsible Party

Jesus Villar

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jesús Villar, MD

Role: STUDY_DIRECTOR

Hospital Universitario Dr. Negrin

Locations

Hospital Universitario Dr. Negrin

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status: RECRUITING

Hospital Clinic

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Hospital Universitario La Princesa

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Jesús Villar, MD

Role: CONTACT

jesus.villar54@gmail.com

+34606860027

Angel Becerra, MD

Role: CONTACT

ang_bcr.bol@hotmail.com

+34676229025

Facility Contacts

Jesús Villar, MD, PhD

Role: primary

jesus.villar54@gmail.com

+34606860027

Angel Becerra, MD

Role: backup

ang_bcr.bol@hotmail.com

+34676229025

Carlos Ferrando, MD, PhD

Role: primary

cafeoranestesia@gmail.com

+34609892732

Fernando Suárez-Sipmann, MD, PhD

Role: primary

fsuarezsipmann@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 234174 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10793162 (View on PubMed)

Other Identifiers

170090

Identifier Type: -

Identifier Source: org_study_id