High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Br… (NCT05904652) | Clinical Trial Compass
CompletedNot Applicable
High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties
United Kingdom2 participantsStarted 2023-09-11
Plain-language summary
The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. The main questions it aims to answer are:
* What is the recruitment rate to the study over 12 months?
* Is the study design acceptable and safe to participants?
Participants will receive high flow nasal oxygen before their breathing tube is removed. The investigators will compare this with standard practice of applying conventional, low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion.
The investigators hypothesise that they will recruit 30 participants to the study protocol (15 participants in each group) over 12 months and that our study protocol will be tolerable and acceptable to participants.
Who can participate
Age range
18 Years – 80 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:
* Participant aged 18 to 80 years old at time of recruitment to study)
* Ventilated for greater than or equal to 48 hours with respiratory failure
* Treating clinician agrees ready for a planned extubation (but pressure support ventilation, fraction of inspired oxygen less than or equal to 40 , positive end expiratory pressure less than or equal to 10 centimetres of water, Respiratory rate less than 20 breaths per minute)
* Minimal secretions
* Neurologically intact (In the opinion of the treating clinician, the participant is unlikely to fail extubation due to their neurological status)
* Cardiovascularly stable (systolic blood pressure greater than or equal to 70 millimetres of mercury, heart rate less than or equal to 150 beats per minute)
* Written informed consent
Exclusion Criteria:
* Cardiac Implant Device
* Internal Neurostimulator
* Unstable Spinal Fracture or Spinal Cord Injury
* Body Mass Index \>50kg/m\^2
* Skin lesions or dressings over electrode belt site
* Pregnancy or Lactating
* Intercostal Chest Drain (at treating clinician's discretion)
* Severe type II respiratory failure (arterial partial pressure of carbon dioxide greater than or equal to 12 kilopascals)
* Severe acidosis (Hydrogen ion concentration greater than or equal to 80 nanomoles per litre)
* Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V)
* Severe heart failure (New York Heart Association Grade III or IV)
* Decreased GCS
* Cardiov…
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
The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.