High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties

Not Applicable

Recruiting

• Conditions: Respiratory Insufficiency

• Registration Number: NCT05904652
• Lead Sponsor: NHS Greater Glasgow and Clyde

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-15
• Study Start: 2023-09-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-09-07
• Study Completion: 2024-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.	72 hours	This will focus primarily on aspects of SAFEx and Electrical Impedance Tomography Measurement.
Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.	72 hours	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
The rate of completion of the SAFEx weaning protocol.	2 hours 50 minutes	The percentage of participants who completed the weaning protocol without breaching any of the physiological participant safety criteria.
The reintubation rate in each group.	72 hours	The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation.
Withdrawal rate from the study.	72 hours	The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures.
The duration of weaning tolerated before desaturation occurred.	2 hours 50 minutes	The average fraction of inspired oxygen and oxygen flow rate administered in each group before desaturation occurred.
The change in global electrical impedance between each group.	2 hours 50 minutes	The change in end expiratory lung impedance and delta impedance between each group.
The failure rate of Electrical Impedance Tomography measurement.	2 hours 50 minutes	Defined as the proportion of participants in whom impedance data cannot be computed.
The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.	72 hours	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

Trial Locations

Locations (1)

Department of Critical Care Medicine, Queen Elizabeth University Hospital; 🇬🇧 Glasgow, Scotland, United Kingdom