Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202631
Status:
UNKNOWN
Last Update Posted:
2006-11-28
First Post:
2005-09-12
Brief Title:
Abdominal Functional Electrical Stimulation in Tetraplegia
Sponsor:
South Glasgow University Hospitals NHS Trust
Organization:
South Glasgow University Hospitals NHS Trust
Study Overview
Official Title:
Abdominal Functional Electrical Stimulation to Augment Breathing in Tetraplegia
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with high spinal lesions are at risk of respiratory complications because they have partial or complete paralysis of breathing muscles Previous work has shown that tetraplegic lung volumes can be increased by using abdominal FES during expiration The technique is attractive because it is non-invasive painless in tetraplegia and completely reversible It may provide a treatment for augmenting the patients breathing both in the acute presentation of spinal injury when half of cervical injuries require ventilation and in long term management of tetraplegia and high paraplegia We propose a pilot study in a small group of subjects to see if the technique is feasible from both a clinical and engineering viewpoint The aims of the study are 1To examine the effects of abdominal FES on lung mechanics and gas exchange in tetraplegic subjects 2To optimise the stimulation pattern and intensity via electronic stimulators and to design a trigger to allow the FES to follow the subjects own breathing cycle automatically
Detailed Description:
Patients with high spinal cord injury SCI usually have paralysed intercostal muscles and rely on diaphragm function alone for respiration They have low tidal volumes and inadequate cough These patients are vulnerable to respiratory complications in the immediate post-injury phase and remain at life-long risk of chest problems Usual treatments include intensive physiotherapy and intermittent positive pressure ventilation to augment the patients tidal volume and to help clear excess secretions
Tidal volumes can also be increased by electrical stimulation of the surface of abdominal muscles during expiration During stimulation the patient expires below functional residual capacity the amount of air left after normal expiration The natural elasticity of the chest wall then causes a recoil increase in the size of the next inspired breath Functional electrical stimulation FES of the abdominal muscles is theoretically an attractive technique to augment respiration It is non-invasive it mimics natural physiological processes and tetraplegic patients cannot sense abdominal discomfort There are potential applications in acute SCI patients to prevent the need for artificial ventilation and to aid ventilator weaning The technique could also be used in chronically injured patients to augment ventilation
Clinical staff at the Queen Elizabeth National Spinal Injuries Unit have collaborated extensively with engineering and bioengineering teams from Glasgow University and the University of Strathclyde in the use of FES in SCI FES is already being used successfully in the Unit for paraplegic cycling and upper limb exercise in tetraplegia We have performed abdominal FES on one SCI subject with complete diaphragm paralysis and produced a tidal volume of one hundred millilitres McLean and Hunt unpublished observation
Before starting a large scale project it is important to confirm whether we can reliably reproduce at least some of the findings of Stanic et al It would be very interesting if we could show any change in gas exchange as well as simply increasing tidal volume Engineering issues include optimisation and programming of the FES stimulus We propose a pilot study in QENSIU to establish whether the technique is of practical benefit to spinal cord injured patients
Tidal volumes can also be increased by electrical stimulation of the surface of abdominal muscles during expiration During stimulation the patient expires below functional residual capacity the amount of air left after normal expiration The natural elasticity of the chest wall then causes a recoil increase in the size of the next inspired breath Functional electrical stimulation FES of the abdominal muscles is theoretically an attractive technique to augment respiration It is non-invasive it mimics natural physiological processes and tetraplegic patients cannot sense abdominal discomfort There are potential applications in acute SCI patients to prevent the need for artificial ventilation and to aid ventilator weaning The technique could also be used in chronically injured patients to augment ventilation
Clinical staff at the Queen Elizabeth National Spinal Injuries Unit have collaborated extensively with engineering and bioengineering teams from Glasgow University and the University of Strathclyde in the use of FES in SCI FES is already being used successfully in the Unit for paraplegic cycling and upper limb exercise in tetraplegia We have performed abdominal FES on one SCI subject with complete diaphragm paralysis and produced a tidal volume of one hundred millilitres McLean and Hunt unpublished observation
Before starting a large scale project it is important to confirm whether we can reliably reproduce at least some of the findings of Stanic et al It would be very interesting if we could show any change in gas exchange as well as simply increasing tidal volume Engineering issues include optimisation and programming of the FES stimulus We propose a pilot study in QENSIU to establish whether the technique is of practical benefit to spinal cord injured patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None