TerminatedNot Applicable

Two Modes of Mechanical Ventilation for Intensive Care Patients With Low Blood Oxygen Due to Breathing Difficulties

Stopped: The study was terminated early due to slower than expected recruitment and limited resources for further enrollment.

Denmark45 participantsStarted 2023-12-08

Plain-language summary

The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Median peak transpulmonary pressure

Timeframe: During the observation period; 1-6 hours after randomization

Trial details

NCT IDNCT06140056

SponsorUniversity Hospital Bispebjerg and Frederiksberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-03

View on ClinicalTrials.gov More Hypoxic Respiratory Failure trials