Back to resultsHigh Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties (Pre-SAFEx)
Primary Purpose
Respiratory Insufficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fisher and Paykel "HealthCare Airvo™ 3" high flow system
Conventional Oxygen Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Insufficiency focused on measuring Extubation Failure, Airway Extubation, Oxygen Inhalation Therapy, Electric Impedance
Eligibility Criteria
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
Sites / Locations
- Department of Critical Care Medicine, Queen Elizabeth University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SAFEx
Standard Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.
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
The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.
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.
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.
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.
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.
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.
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.
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.
The change in end expiratory lung impedance and delta impedance between each group.
The reintubation rate in each group.
The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation.
Full Information
NCT ID
NCT05904652
First Posted
May 31, 2023
Last Updated
June 12, 2023
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Fisher and Paykel Healthcare, LINET
1. Study Identification
Unique Protocol Identification Number
NCT05904652
Brief Title
High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties
Acronym
Pre-SAFEx
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Fisher and Paykel Healthcare, LINET
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Extubation Failure, Airway Extubation, Oxygen Inhalation Therapy, Electric Impedance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised in a 1:1 manner between two treatments at time of extubation: SAFEx treatment or standard care.
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAFEx
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fisher and Paykel "HealthCare Airvo™ 3" high flow system
Intervention Description
High Flow Nasal Oxygen Delivery Device
Intervention Type
Device
Intervention Name(s)
Conventional Oxygen Therapy
Intervention Description
Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)
Primary Outcome Measure Information:
Title
The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.
Description
This will focus primarily on aspects of SAFEx and Electrical Impedance Tomography Measurement.
Time Frame
72 hours
Title
Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.
Description
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
Time Frame
72 hours
Title
Withdrawal rate from the study.
Description
The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures.
Time Frame
72 hours
Title
The rate of completion of the SAFEx weaning protocol.
Description
The percentage of participants who completed the weaning protocol without breaching any of the physiological participant safety criteria.
Time Frame
2 hours 50 minutes
Title
The duration of weaning tolerated before desaturation occurred.
Description
The average fraction of inspired oxygen and oxygen flow rate administered in each group before desaturation occurred.
Time Frame
2 hours 50 minutes
Title
The failure rate of Electrical Impedance Tomography measurement.
Description
Defined as the proportion of participants in whom impedance data cannot be computed.
Time Frame
2 hours 50 minutes
Title
The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.
Description
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
Time Frame
72 hours
Title
The change in global electrical impedance between each group.
Description
The change in end expiratory lung impedance and delta impedance between each group.
Time Frame
2 hours 50 minutes
Title
The reintubation rate in each group.
Description
The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
Phone
+44(0)1412014500
Email
malcolm.sim@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Malcolm J Watson, MBChB, PhD, MRCP, FRCA
Phone
+44(0)1412014500
Email
malcolm.watson@ggc.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Critical Care Medicine, Queen Elizabeth University Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
Phone
+44(0)1412014500
Email
malcolm.sim@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Barbara Ross, BSc (Hons)
Phone
+44(0)1413144011
Email
barbara.ross@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Duncan G Thomson, MBChB
First Name & Middle Initial & Last Name & Degree
Malcolm J Watson, MBChB, PhD, MRCP, FRCA
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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)
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12548031
Citation
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High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties
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