NCT Number: NCT07437846
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Santiago, Santiago Metropolitan, Chile
Location status: Recruiting
Diego Lopez Arnello, Physioterapy
CONTACT
Diego Lopez Arnello, Physioterapy
PRINCIPAL_INVESTIGATOR
Felipe Damiani, PhD, Msc, Physioterapy
PRINCIPAL_INVESTIGATOR
Roque Basoalto, PhD, Msc, Physioterapy
CONTACT
Roque Basoalto, PhD, Msc, Physioterapy
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Positive end-expiratory pressure (PEEP) will be adjusted to four predefined levels (0, 5, 10, and 15 cmH₂O) following a randomized crossover protocol during assisted mechanical ventilation. Only the PEEP level will be modified, while all other ventilator settings will be kept constant. Each PEEP level will be maintained for 15 minutes, followed by a 15-minute washout period between levels. Physiological measurements will be obtained during the last 5 minutes of each PEEP level, including respiratory effort assessed using invasive and non-invasive methods, respiratory mechanics, and hemodynamic parameters.
Other names: PEEP levels
Time frame: During the last 5 minutes of each PEEP level
Esophageal pressure swing (ΔPes), defined as the absolute difference between end-expiratory and end-inspiratory esophageal pressure, measured using an esophageal balloon catheter.
Time frame: During the last 5 minutes of each PEEP level
Pressure-time product per minute (PTPmin), expressed as cmH₂O·s/min, measured using an esophageal balloon catheter as an index of global inspiratory effort.
Time frame: During the last 5 minutes of each PEEP level
Airway occlusion pressure-derived index (ΔPocc) obtained from brief ventilator-based airway occlusion maneuvers as a non-invasive measurement of inspiratory effort.
Time frame: During the last 5 minutes of each PEEP level
Muscular Pressure Index (PMI) calculated from ventilator-based airway occlusion maneuvers as a non-invasive estimate of inspiratory muscle pressure.
Time frame: During the last 5 minutes of each PEEP level
Airway occlusion pressure at 100 milliseconds (P0.1), measured by the mechanical ventilator as an index of respiratory drive.
Time frame: During the last 5 minutes of each PEEP level
Static compliance of the respiratory system (Cest) measured during assisted mechanical ventilation at each PEEP level.
Time frame: During the last 5 minutes of each PEEP level
Driving pressure calculated as the difference between airway plateau pressure and total PEEP during assisted mechanical ventilation at each PEEP level.
Time frame: During the last 5 minutes of each PEEP level
Airway plateau pressure measured during assisted mechanical ventilation at each PEEP level.
Time frame: During the last 5 minutes of each PEEP level
Hemodynamic response assessed using heart rate, arterial blood pressure, respiratory rate and oxygen saturation during assisted mechanical ventilation at different PEEP levels.
Time frame: During the last 5 minutes of each PEEP level
Gas exchange assessed using the SaFi index (SpO₂/FiO₂ ratio) at each PEEP level.
Time frame: During the last 5 minutes of each PEEP level
ynamic transpulmonary pressure calculated during assisted mechanical ventilation using airway pressure and esophageal pressure measurements obtained with an esophageal balloon catheter.
Contact information is provided by the study sponsor or research team.
Diego Lopez Arnello, Physioterapy
CONTACT
Felipe Damiani, PhD, Msc, Physioterapy
CONTACT
Pontificia Universidad Catolica de Chile
Other
Impact of Positive End-Expiratory Pressure on the Modulation of Respiratory Effort During Assisted Ventilation: A Physiological Randomized Crossover Study
Acronym: PEEP-EFFORT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06737432
ARDS, Lung Diseases
Galveston, Texas, United States
View Trial DetailsNCT07114289
Body Weight, Extubation
Taipei, Taiwan
View Trial DetailsNCT05751863
Agnosia, Mechanical Ventilation
Long Beach, California, United States
View Trial DetailsNCT07001696
Critical Illness, Disease Attributes
Zagazig, Al Sharqia, Egypt
View Trial Details