CompletedNot Applicable

Closed Loop Mechanical Ventilation and ECMO

62 participantsStarted 2016-03-06

Plain-language summary

Mechanical ventilation and ECMO are both technologies interacting on gas exchange. Nevertheless, besides a consensus paper, no evidence-based guidelines regarding protective lung ventilation on ECMO exist to date. Mechanical Ventilation with Intellivent-ASV, an algorithm driven, closed loop system, provides an opportunity to standardize ventilation on ECMO. We propose and validate lung protective ventilation with a closed loop ventilation mode in patients with ECMO.

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: * Mechanical Ventilation and ECMO * Refractory Acute Respiratory Distress Syndrome or Refractory Cardiogenic Shock Exclusion Criteria: * Contraindications for ECMO * Contraindications for Closed Loop Ventilation * Rejection of participation

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

Change in Tidal Volumes

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Driving Pressure

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Peak Pressure

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Mechanical Power

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Partial Pressure of Arterial Oxygen

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Partial Pressure of Arterial CO2

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Trial details

NCT IDNCT04925518

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-23

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials

Plain-language summary

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.

What they're measuring

Change in Tidal Volumes

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Driving Pressure

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Peak Pressure

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Mechanical Power

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Partial Pressure of Arterial Oxygen

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Change in Partial Pressure of Arterial CO2

Timeframe: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours