Respiratory Insufficiency
Conditions
Keywords
Extubation Failure, Airway Extubation, Oxygen Inhalation Therapy, Electric Impedance
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.
Interventions
DEVICEFisher and Paykel "HealthCare Airvo™ 3" high flow system
High Flow Nasal Oxygen Delivery Device
Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)
Sponsors
NHS Greater Glasgow and Clyde
Fisher and Paykel Healthcare
LINET
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Participants will be randomised in a 1:1 manner using a computer-generated 30 number sequence of '1s' and '2s' from https://www.random.org/ between 1) SAFEx treatment and 2) standard care. A clinician, not involved in the study, will obtain this 30 number sequence and conceal its order within 30 sealed, opaque, numbered envelopes. The investigators will be blinded to the participant's allocation until they have been enrolled in the study, after which the next envelope in the sequence will be opened and treatment allocation will be unblinded.
Intervention model description
Participants will be randomised in a 1:1 manner between two treatments at time of extubation: SAFEx treatment or standard care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 |
| 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 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. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORMalcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
NHS Greater Glasgow and Clyde
Outcome results
None listed