PEEP in Patients With Acute Respiratory Failure

NCT04912960 | Recruiting

• 1 other identifier: 170090
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Respiratory Failure With Hypoxia

Outcome Measures

Primary Outcomes (3)

• static compliance of the respiratory system

  ratio of tidal volume to pressure gradiente of the respiratory system

  at study enrollment

• oxygen transport

  Cardiac output multiply by oxygen content in arterial blood

  at study enrollment

• dead space fraction

  ratio of dead space to tidal volume

  at study enrollment

Interventions

Mechanical ventilation DEVICE

Optimum PEEP

Also known as: positive end-expiratory pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients with hypoxemic respiratory failure (PaO2/FiO2 \<300 on FiO2 equal or greater than 0.3)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jesus Villar: lead

Study Sites (3)

Hospital Universitario Dr. Negrin

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario La Princesa

Madrid, Spain

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 234174 BACKGROUND

• 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.

  PMID: 10793162 BACKGROUND

MeSH Terms

Interventions

Respiration, Artificial; Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Jesús Villar, MD

  Hospital Universitario Dr. Negrin

  STUDY DIRECTOR

Central Study Contacts

Jesús Villar, MD

CONTACT

+34606860027; jesus.villar54@gmail.com

Angel Becerra, MD

CONTACT

+34676229025; ang_bcr.bol@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 3, 2021
• Study Start: June 10, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)