Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients (NCT06521489) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients
Greece63 participantsStarted 2024-05-01
Plain-language summary
High-flow oxygen therapy has been applied after extubation in cardiac surgery patients with a well-known successful efficacy. The current authors plan to conduct a prospective, randomized, controlled study of the Asymmetrical device Nasal Cannula High Flow Oxygenation (HFNCO) application on high flow (60L/min) with 60% fiO2 administration versus Conventional device Nasal Cannula High Flow Oxygenation (HFNCO) application on high flow (60L/min) with 60% fiO2 administration and versus Conventional oxygen treatment (Venturi mask) after extubation of patients undergoing elective or non-elective cardiac surgery.
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:
* Cardiac ICU adult patients
* \>18 years
* After elective or urgent cardiac surgery
* Successful Spontaneous Breathing Trial (SBT) with T-piece and FiO2=60%.
* pO2/ FiO2 \<150
* Hemodynamically stable (160\>SAP\>90mmHg)
Exclusion Criteria:
* Obstructive Sleep Apnea Syndrome supported by CPAP mask on ventilator
* COPD, officially diagnosed, respiratory failure - on exacerbation with serum blood pH \<7,35.
* Patients with tracheostomy,
* DNR status,
* Glasgow Coma Scale score \< 13,
* Insufficient knowledge of the Greek Language
* Visual or hearing impairment.
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
1
Successful weaning (i.e. absence of treatment failure) from Asymmetrical Nasal Cannula High Flow Oxygenation post-extubation from cardiac surgery within at least 48 hours
Timeframe: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)]
Trial details
NCT IDNCT06521489
SponsorNational and Kapodistrian University of Athens