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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
High Flow Nasal Oxygen Delivery Device
Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)
Department of Critical Care Medicine, Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
RECRUITINGThe recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.
The associated end point will be the average rate of recruitment per month over 12 months of participants who complete the full study protocol (with a set upper limit of 30 participants recruited to the protocol over 12 months corresponding to a recruitment rate of 2.5 participants per month).
Time frame: 12 months
The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.
This will focus primarily on aspects of SAFEx and Electrical Impedance Tomography Measurement.
Time frame: 72 hours
Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.
Questions will ask participants to rate their experience on a 1 to 10 scale for: * Overall comfort * Perceived dyspnoea * Ability to speak * Ability to hear * Ability to clear secretions * Sensation of bloating * Sensation of dry mouth * Sensation of nasal dryness * Fear
Time frame: 72 hours
Withdrawal rate from the study.
The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures.
Time frame: 72 hours
The rate of completion of the SAFEx weaning protocol.
The percentage of participants who completed the weaning protocol without breaching any of the physiological participant safety criteria.
Time frame: 2 hours 50 minutes
The duration of weaning tolerated before desaturation occurred.
The average fraction of inspired oxygen and oxygen flow rate administered in each group before desaturation occurred.
Time frame: 2 hours 50 minutes
The failure rate of Electrical Impedance Tomography measurement.
Defined as the proportion of participants in whom impedance data cannot be computed.
Time frame: 2 hours 50 minutes
The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.
Questions will ask participants to rate their experience on a 1 to 10 scale for: * Overall comfort whilst wearing EIT * Overall comfort on removal of EIT * Overall ease of breathing with EIT
Time frame: 72 hours
The change in global electrical impedance between each group.
The change in end expiratory lung impedance and delta impedance between each group.
Time frame: 2 hours 50 minutes
The reintubation rate in each group.
The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation.
Time frame: 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.