Clinical trial NCT05904652: High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Extubation Failure
Airway Extubation
Oxygen Inhalation Therapy
Electric Impedance
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
name: LINET
First posted: 2023-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised in a 1:1 manner between two treatments at time of extubation: SAFEx treatment or standard care.
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.
timeFrame: 12 months
Secondary outcomes:
measure: The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.
timeFrame: 72 hours
measure: Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.
timeFrame: 72 hours
measure: Withdrawal rate from the study.
timeFrame: 72 hours
measure: The rate of completion of the SAFEx weaning protocol.
timeFrame: 2 hours 50 minutes
measure: The duration of weaning tolerated before desaturation occurred.
timeFrame: 2 hours 50 minutes
measure: The failure rate of Electrical Impedance Tomography measurement.
timeFrame: 2 hours 50 minutes
measure: The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.
timeFrame: 72 hours
measure: The change in global electrical impedance between each group.
timeFrame: 2 hours 50 minutes
measure: The reintubation rate in each group.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Department of Critical Care Medicine, Queen Elizabeth University Hospital
state: Scotland
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
role: PRINCIPAL_INVESTIGATOR
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