High Flow Oxygen Therapy After Spinal Cord Injury
1 other identifier
interventional
30
1 country
1
Brief Summary
The goal of this feasibility study is to learn about the ability to use a different form of oxygen therapy (known as high flow oxygen therapy) in patients who have a spinal cord injury in the upper back or neck. The main questions it aims to answer are:
- 1.Is it possible to recruit patients to the study
- 2.It is possible to follow the protocol in its current format
- 3.What is the impact on those receiving the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
August 5, 2025
July 1, 2025
2.2 years
December 8, 2023
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment rates
This will explore the ability to recruit eligible participants in a timely fashion as per the protocol. It will also capture the participant retainment rates during the study E.g., number of patients recruited, and % of those recruited completing study
10 days
Secondary Outcomes (5)
To determine the acceptability of the intervention
10 days
Physiotherapy time
10 days
Frequency of physiotherapy interventions
10 days
Pulmonary complications
10 days
Incidence of ICU admission
10 days
Study Arms (2)
Intervention
EXPERIMENTALHigh flow oxygen therapy delivered via nasal cannalue
Control
NO INTERVENTIONStandard care with oxygen therapy as required.
Interventions
High flow oxygen therapy delivered via nasal cannulae, at 50 litres flow with variable oxygen levels
Eligibility Criteria
You may qualify if:
- Spinal cord injury between C4 and T4 (Include ASIA A-D)
- Admitted to spinal injury ward within 24-48hours of injury
You may not qualify if:
- Aged under 18 years
- or more rib fractures or flail
- Sternal fracture
- Concomitant lung injury
- Unable to gain informed consent from participant
- Contra-indication to using high flow therapy e.g., undrained pneumothorax, facial fractures, nasal obstruction, CSF leak, suspected or confirmed base of skull fracture, active epistaxis or recent functional endoscopic sinus surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiff and Vale University Health Board
Cardiff, CF144XW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Twose
Cardiff and Vale University Health Board
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2023
First Posted
February 6, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
No plan to for IPD sharing