High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties (Pre-SAFEx)

NHS Trust

Status: Enrolling

Conditions: Respiratory Insufficiency

Treatments: Device: Fisher and Paykel "HealthCare Airvo™ 3" high flow system; Device: Conventional Oxygen Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05904652

GN23CC122

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

SAFEx

Experimental group

Description:

Electrical Impedance Tomography recording is commenced 15 minutes prior to planned extubation. High Flow Nasal Therapy (HFNT) is commenced at least 10 minutes prior to planned extubation. At 5 minutes before extubation, the flow rate of HFNT should be established at 60 litres per min (or as high as can be tolerated by the participant) and the fraction of inspired oxygen (FiO2) set at 40 percent. Prior to extubation, endotracheal, infraglottic and supraglottic suctioning are performed. Then, the cuff is let down followed by immediate extubation with simultaneous application of HFNT. 10 minutes after extubation, the FiO2 is weaned in a protocolised manner to 21 percent - or as close to 21 percent as possible over 25 minutes. If the participant is safely weaned onto room air, the flow rate of HFNT is then reduced in a protocolised manner over 120 minutes: 60 minutes at 60 litres per minute (or the highest flow rate tolerated) and then 60 minutes at 30 Litres per minute.

Treatment:

Device: Fisher and Paykel "HealthCare Airvo™ 3" high flow system

Standard Care

Active Comparator group

Description:

Electrical Impedance Tomography recording commenced 15 minutes prior to planned extubation. Prior to extubation, endotracheal, infraglottic and supraglottic suctioning are performed. Then, the cuff is let down followed by immediate extubation on to low flow conventional oxygen with a fraction of inspired oxygen of up to 40 percent. Then, the participant is weaned at the discretion of their clinician over the next 2 hours and 35 minutes.

Treatment:

Device: Conventional Oxygen Therapy