Comparing two types of mechanical ventilation for ICU patients with low blood oxygen
Transpulmonary Pressure During Volume Controlled Mechanical Ventilation Versus Airway Pressure Release Ventilation for Hypoxic Respiratory Failure - a Randomized Feasibility Study
This study tests whether two different types of breathing machines can help ICU patients with low blood oxygen breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 2 sites (Hvidovre and 1 other locations) |
| Trial ID | NCT06140056 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different modes of mechanical ventilation on patients in the intensive care unit who are experiencing breathing difficulties and low blood oxygen levels. Patients will be randomly assigned to receive either airway pressure release ventilation or volume-controlled mechanical ventilation, with their lung pressures monitored using esophageal manometry. The study aims to improve the management of hypoxic respiratory failure by analyzing changes in lung pressure and comparing the effectiveness of the two ventilation methods. The trial will include an adjustment phase followed by an observation period to assess the outcomes of each ventilation mode.
Who should consider this trial
Good fit: Ideal candidates for this study are ICU patients requiring invasive mechanical ventilation with significant oxygenation challenges.
Not a fit: Patients with severe bronchospasm, emphysema, or hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies for patients with hypoxic respiratory failure, enhancing their oxygenation and overall recovery.
How similar studies have performed: Other studies have explored mechanical ventilation strategies, but this specific comparison of airway pressure release ventilation versus volume-controlled ventilation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to the ICU * Invasive mechanical ventilation with FiO2 ≥ 50% OR PaO2-to-FiO2 ratio \<20 kPa, including PEEP 3 5 cmH20 for at least 6 hours Exclusion Criteria: * Meeting inclusion criteria for more than 24 hours * Severe bronchospasm, defined as warranting treatment aimed at reversing this i.e. inhalation of anticholinergic or bronchodilator beyond what the patient normally use * Emphysema where treating physician judges the patient at increased risk for pneumothorax from APRV * Restrictive lung disease defined as a pre-admission diagnosis of restrictive lung disease * Undrained pneumothorax * Hemodynamic instability defined as more than 0.20 microgram/kg/min of norepinephrine or any dose of adrenaline infusion to maintain MAP ≥ 65 mmHg * Age \< 18 years * Patients who have received APRV previously during the current ICU admission * Patients in prone position within the last 24 hours
Where this trial is running
Hvidovre and 1 other locations
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
- Bispebjerg Hospital — København, Denmark (Recruiting)
Study contacts
- Principal investigator: Theis S Itenov, MD, PhD — University Hospital Bispebjerg and Frederiksberg
- Study coordinator: Theis Itenov, Md, PhD
- Email: theis.skovsgaard.itenov@regionh.dk
- Phone: +4551341945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.