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

November 30, 2023 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Recruiting
        • Department of Critical Care Medicine, Queen Elizabeth University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Duncan G Thomson, MBChB
        • Sub-Investigator:
          • Malcolm J Watson, MBChB, PhD, MRCP, FRCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAFEx
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.
Device: Fisher and Paykel "HealthCare Airvo™ 3" high flow system
High Flow Nasal Oxygen Delivery Device
Active Comparator: Standard Care
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.
Device: Conventional Oxygen Therapy
Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours
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
72 hours
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.
72 hours
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.
2 hours 50 minutes
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.
2 hours 50 minutes
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.
2 hours 50 minutes
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
72 hours
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.
2 hours 50 minutes
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.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Fisher and Paykel Healthcare
LINET

Investigators

  • Principal Investigator: Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM, NHS Greater Glasgow and Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Estimated)

September 7, 2024

Study Completion (Estimated)

September 7, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN23CC122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised, processed Physiological, EIT and Questionnaire Data that underlies the results reported in this study will be be made available . Raw data will not be shared.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

Appropriate request made through Enlighten Data Repository (doi will be provided in future publication)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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