The use of bronchodilators in people with recently acquired spinal cord injury

Effect of bronchodilators on respiratory function of people with recently acquired spinal cord injury

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000828224

Enrollment

Registered

2009-09-22

Start date

2011-09-30

Completion date

2011-11-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Effect of ventolin vs placebo in acute tetraplegic patients. Spirometric outcome measures

Interventions

Subjects in the treatment group will receive 4 puffs of salbutamol (ventolin)via a spacer. Subjects in the control group will 4 puffs of placebo salbutamol administered in the same way. Both the salbutamol(ventolin) and placebo will be administered with subjects in lying using a fspacer Subjects will not be told whether they are receiving the experimental or sham condition .Within the next week experimental subjects will receive the placebo and control subjects will receive the salbutamol (ventolin) using the same procedure as outline above. In this way, subjects will act as their own controls.Minimum wash out period will be 48 hours. Response to ventolin and placebo will be measured using spirometry and will be compared to a baseline measure of no intervention.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

People with tetraplegia or paraplegia above T4 acquired within 6 weeks of randomisation Motor complete lesion (ie, American Spinal Injuries Association (ASIA)scale A or B with no zones of partial motor preservation) Able to provide informed consent No recent pre morbid history of asthma or premorbid use of bronchodilators not ventilated stable Vital capacity over preceeding 2 days OR stable respiratory status

Exclusion criteria

Not medically stable, requiring ventilatory support with mechanical ventilation via endothracheal tube or tracheostomy Premorbid recent history of asthma or bronchodilator use

Outcome results