Using high flow nasal oxygen to help remove breathing tubes in adults with severe breathing difficulties
A Randomised, Feasibility Trial of Simultaneous Application of Flow at Extubation (SAFEx) in Patients Requiring Intubation and Ventilation for the Management of Acute Respiratory Failure
This study is testing if giving high flow nasal oxygen before removing breathing tubes can help adults with severe breathing problems avoid needing to be put back on a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 1 site (Glasgow, Scotland) |
| Trial ID | NCT05904652 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the safety and acceptability of a new method for removing breathing tubes in adults who have been on mechanical ventilation for respiratory insufficiency. Participants will receive high flow nasal oxygen prior to extubation, compared to the standard practice of low-flow oxygen after extubation. The study will assess recruitment rates and participant tolerance over a 12-month period, with a target of enrolling 30 participants. The goal is to determine if this new approach can reduce the need for re-intubation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have been ventilated for at least 48 hours and are deemed ready for planned extubation.
Not a fit: Patients with unstable cardiovascular conditions, significant obesity, or certain medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the safety and comfort of extubation for patients with severe respiratory difficulties.
How similar studies have performed: While this approach is novel, similar studies exploring high flow oxygen therapy have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Cardiovascular instability (systolic blood pressure less than or equal to 69 millimetres of mercury or heart rate greater than or equal to 151 millimetres of mercury ) * Pulmonary embolism * Nasal obstruction * Previous bleomycin administration * Base of skull fracture * Life expectancy less than or equal to 3 months
Where this trial is running
Glasgow, Scotland
- Department of Critical Care Medicine, Queen Elizabeth University Hospital — Glasgow, Scotland, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM — NHS Greater Glasgow and Clyde
- Study coordinator: Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
- Email: malcolm.sim@ggc.scot.nhs.uk
- Phone: +44(0)1412014500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.