Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07437846

Impact of PEEP on Respiratory Effort During Assisted Ventilation

Led by Pontificia Universidad Catolica de Chile · Updated on 2026-02-27

12

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

P

Pontificia Universidad Catolica de Chile

Lead Sponsor

C

Clínica Universidad de los Andes

Collaborating Sponsor

AI-Summary

What this Trial Is About

Assisted mechanical ventilation is widely used to preserve diaphragmatic activity and improve lung aeration in patients with acute respiratory failure. However, during assisted ventilation, excessive inspiratory effort may develop and contribute to lung injury, diaphragmatic overload, and patient self-inflicted lung injury. Optimizing ventilator settings to modulate respiratory effort therefore represents a major physiological and clinical challenge. Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment and respiratory system mechanics and may influence inspiratory effort by modifying lung volume, compliance, and respiratory drive. Despite its widespread use, PEEP titration in clinical practice is still mainly guided by oxygenation parameters, while its direct effects on inspiratory effort during assisted mechanical ventilation remain insufficiently characterized. This physiological randomized crossover study aims to evaluate the effect of four predefined levels of positive end-expiratory pressure (0, 5, 10, and 15 cmH₂O) on the respiratory system and inspiratory effort in adult patients receiving assisted mechanical ventilation. Patients will be exposed to each PEEP level in randomized order, with stabilization and washout periods between conditions, while ventilatory support settings other than PEEP are kept constant.

CONDITIONS

Official Title

Impact of PEEP on Respiratory Effort During Assisted Ventilation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years
  • ICU patients receiving invasive mechanical ventilation via endotracheal tube or tracheostomy
  • Ventilated in an assisted mode with spontaneous breathing
  • Clinically stable to undergo protocolized PEEP changes
  • Sedation level compatible with spontaneous breathing and ventilator triggering
  • Informed consent from the patient or legally authorized representative
Not Eligible

You will not qualify if you...

  • Contraindication to esophageal balloon placement (if applicable)
  • Significant hemodynamic instability or unstable vasopressor requirements
  • Unstable arrhythmia or active myocardial ischemia
  • Undrained pneumothorax or major air leak
  • Controlled ventilation without effective spontaneous effort (apnea, neuromuscular blockade, deep sedation)
  • Pregnancy
  • Acute or chronic neurological conditions that may impair respiratory drive or interfere with spontaneous breathing regulation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Clinico UC

Santiago, Santiago Metropolitan, Chile

Actively Recruiting

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Research Team

D

Diego Lopez Arnello, Physioterapy

CONTACT

F

Felipe Damiani, PhD, Msc, Physioterapy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

4

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