Unraveling PEEP-effects on respiratory drive and effort

Unraveling PEEP-induced effects on respiratory dRivE and EFfort in acute hypoxemic respiratory failure: the REEF study - Unraveling PEEP-induced effects on respiratory dRivE and EFfort in acute hypoxemic respiratory failure: the REEF study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57928

Enrollment

Registered

2025-05-02

Start date

2025-10-07

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute hypoxemic respiratory failure, acute respiratory distress syndrome (ARDS)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Age > 18 years -Acute hypoxemic respiratory failure (AHRF) with a PaO2/FiO2-ratio = 200 mmHg; -patients on invasive assisted mechanical ventilation exhibiting inspiratory efforts with occlusion pressure > 5 cmH2O

Exclusion criteria

Exclusion criteria: -Pre-existent neuromuscular disease -History of chronic respiratory failure requiring long-term oxygen therapy -Muscle paralysis -Pneumothorax -Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement) -Contra-indications for EAdi or oesophageal balloon catheter placement (e.g. history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage or known/suspected varices)

Design outcomes

Primary

Measure	Time frame
To determine the effect of PEEP on diaphragm neuromechanical efficiency (i.e. an index of neural respiratory drive and inspiratory effort) in patients with acute hypoxemic respiratory failure during invasive assisted mechanical ventilation.	—

Secondary

Measure	Time frame
Secondary endpoints will include: -PEEP-induced effects on partitioned respiratory system mechanics: end-expiratory, end-inspiratory and driving transpulmonary pressure; respiratory system, chest wall and lung compliance -evaluation of expiratory muscle activity -PEEP-induced effects on lung aeration pattern (assessed through electrical impedance tomography): change in end-expiratory lung impedance, change in regional compliance (reflecting collapse/overdistension), distribution of ventilation and homogeneity of lung inflation/deflation, amount of pendelluft -PEEP-induced effects on respiratory muscles geometry and function (assessed through ultrasound): diaphragm thickness, thickening fraction and excursion, diaphragm zone of apposition, abdominal wall muscle thickness and thickening -Evaluation of surface EMG abdominal wall muscles for each PEEP level -Ventilator parameters for each PEEP level: intrinsic positive end-expiratory pressure (PEEPi), plateau pressure (Pplat), peak pressure (Ppeak), static and dynamic compliance, mechanical power, airway flow -Gas exchange for each PEEP level: arterial blood gas parameters -Hemodynamic parameters for each PEEP level: mean, systolic and diastolic pressure, heart rate	—

Measure

Time frame

Secondary endpoints will include: -PEEP-induced effects on partitioned respiratory system mechanics: end-expiratory, end-inspiratory and driving transpulmonary pressure; respiratory system, chest wall and lung compliance -evaluation of expiratory muscle activity -PEEP-induced effects on lung aeration pattern (assessed through electrical impedance tomography): change in end-expiratory lung impedance, change in regional compliance (reflecting collapse/overdistension), distribution of ventilation and homogeneity of lung inflation/deflation, amount of pendelluft -PEEP-induced effects on respiratory muscles geometry and function (assessed through ultrasound): diaphragm thickness, thickening fraction and excursion, diaphragm zone of apposition, abdominal wall muscle thickness and thickening -Evaluation of surface EMG abdominal wall muscles for each PEEP level -Ventilator parameters for each PEEP level: intrinsic positive end-expiratory pressure (PEEPi), plateau pressure (Pplat), peak pressure (Ppeak), static and dynamic compliance, mechanical power, airway flow -Gas exchange for each PEEP level: arterial blood gas parameters -Hemodynamic parameters for each PEEP level: mean, systolic and diastolic pressure, heart rate

—

Countries

Netherlands

Contacts

Public ContactT. Rosà

Radboud Universitair Medisch Centrum

tommaso.rosa@radboudumc.nl0243665010

Outcome results