Skip to main content
OpenTrials
Completed

NCT Number: NCT05904652

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Critical Care Medicine, Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

High Flow Nasal Oxygen Delivery Device

Conventional Oxygen Therapy

Device

Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)

Primary outcomes

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

    Time frame: 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 outcomes

  1. The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.

    Time frame: 72 hours

    This will focus primarily on aspects of SAFEx and Electrical Impedance Tomography Measurement.

  2. Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.

    Time frame: 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

  3. Withdrawal rate from the study.

    Time frame: 72 hours

    The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures.

  4. The rate of completion of the SAFEx weaning protocol.

    Time frame: 2 hours 50 minutes

    The percentage of participants who completed the weaning protocol without breaching any of the physiological participant safety criteria.

  5. The duration of weaning tolerated before desaturation occurred.

    Time frame: 2 hours 50 minutes

    The average fraction of inspired oxygen and oxygen flow rate administered in each group before desaturation occurred.

  6. The failure rate of Electrical Impedance Tomography measurement.

    Time frame: 2 hours 50 minutes

    Defined as the proportion of participants in whom impedance data cannot be computed.

  7. The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.

    Time frame: 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

  8. The change in global electrical impedance between each group.

    Time frame: 2 hours 50 minutes

    The change in end expiratory lung impedance and delta impedance between each group.

  9. The reintubation rate in each group.

    Time frame: 72 hours

    The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation.

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • Fisher and Paykel Healthcare
  • LINET

Registry information

Official study 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

Acronym: Pre-SAFEx

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.