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 range18 Years – 80 Years

SexALL

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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…

What they're measuring

The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.

Timeframe: 12 months

Trial details

NCT IDNCT05904652

SponsorNHS Greater Glasgow and Clyde

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-10