Health TrialsbyHealthPanel

High Flow Oxygen Therapy After Spinal Cord Injury

ConditionsSpinal Cord InjuriesRespiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiff and Vale University Health Board

About this trial

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.

Participants will be randomised to receive either standard care or high flow oxygen therapy for 10 days following inclusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Spinal cord injury between C4 and T4 (Include ASIA A-D)

Admitted to spinal injury ward within 24-48hours of injury

Disqualifiers

Aged under 18 years

3 or more rib fractures or flail

Sternal fracture

Concomitant lung injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • High flow oxygen therapy

    Other intervention

    High flow oxygen therapy delivered via nasal cannulae, at 50 litres flow with variable oxygen levels

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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

Time frame
10 days

Secondary outcomes

1

To determine the acceptability of the intervention

To see if the protocol can be followed and patients can receive the intervention - do all patients receive the intervention as planned, or is there any cross-over of interventions. E.g. % of participants completing the intervention as planned

Time frame
10 days
2

Physiotherapy time

Duration (minutes) of physiotherapy intervention during the study period

Time frame
10 days
3

Frequency of physiotherapy interventions

To understand whether the chosen outcome measures are appropriate - is it appropriate and possible to capture the frequency of physiotherapy intervention during the study period

Time frame
10 days
4

Pulmonary complications

Incidence of pulmonary complications following spinal cord injury using the brooks-braun classification

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardiff and Vale University Health Board

Lead sponsor

Source ClinicalTrials.gov
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