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

Last updated: November 30, 2023
Sponsor: NHS Greater Glasgow and Clyde
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Conventional Oxygen Therapy

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

Clinical Study ID

NCT05904652
GN23CC122
  • Ages 18-80
  • All Genders

Study 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

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 supportventilation, fraction of inspired oxygen less than or equal to 40 , positive endexpiratory pressure less than or equal to 10 centimetres of water, Respiratory rateless than 20 breaths per minute)
  • Minimal secretions
  • Neurologically intact (In the opinion of the treating clinician, the participant isunlikely to fail extubation due to their neurological status)
  • Cardiovascularly stable (systolic blood pressure greater than or equal to 70millimetres of mercury, heart rate less than or equal to 150 beats per minute)
  • Written informed consent

Exclusion

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 dioxidegreater than or equal to 12 kilopascals)
  • Severe acidosis (Hydrogen ion concentration greater than or equal to 80 nanomoles perlitre)
  • Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IVor V)
  • Severe heart failure (New York Heart Association Grade III or IV)
  • Decreased GCS
  • Cardiovascular instability (systolic blood pressure less than or equal to 69millimetres of mercury or heart rate greater than or equal to 151 millimetres ofmercury )
  • Pulmonary embolism
  • Nasal obstruction
  • Previous bleomycin administration
  • Base of skull fracture
  • Life expectancy less than or equal to 3 months

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Conventional Oxygen Therapy
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
September 07, 2024

Connect with a study center

  • Department of Critical Care Medicine, Queen Elizabeth University Hospital

    Glasgow, Scotland G51 4TF
    United Kingdom

    Active - Recruiting

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