Blood Pressure
Conditions
Keywords
Antishock Garment
Brief summary
Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). Each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.
Detailed description
Primary Aim: To determine how blood flow restriction to the lower extremities using non-pneumatic anti-shock garments affects hemodynamic and cardiovascular parameters such as blood pressure in Hemodialysis (HD) patients while they are not on dialysis. Investigators propose a pilot study to assess the effects of blood flow restriction using non-pneumatic anti-shock garments in HD patients while they are not on dialysis. Outcomes: The primary objective will be a measurement of blood pressure upon application of the non-pneumatic anti-shock garments. Secondary outcomes will include the following: baroreflex sensitivity; trends in beat-to-beat blood pressure upon application of the anti-shock garments; patient tolerability of the non-pneumatic anti-shock garments, ejection fraction via echocardiogram analyses.
Interventions
DEVICEApplication of Antishock garment
anti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy participants 1. Male and female, age≥18 years old 2. No clinical diagnosis of CKD CKD patients not on dialysis 1. Male and female, age≥18 years old 2. Stage 4 or Stage 5 CKD patients CKD patients on dialysis 1. Male and female, age≥18 years old 2. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
Exclusion criteria
1. Not meeting inclusion criteria 2. Severe heart failure (New York Heart Association grade IV) 3. Pulmonary hypertension 4. Mitral stenosis 5. Cardiac transplant recipients 6. Mental incapacity to consent 7. Declined to participate 8. Absence of lower limbs or lower limb injury 9. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of blood pressure changes with and without garment application | Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. | a measurement of blood pressure upon application of the non-pneumatic anti-shock garments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of changes in Baroreflex Sensitivity with and without garment application. | Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. | baroreflex sensitivity; upon application of the anti-shock garments; |
| Assessment of changes in trends in beat to beat blood pressure with and without garment application. | Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. | trends in beat-to-beat blood pressure upon application of the anti-shock garments |
| Assessment of participant tolerability with garment application. | Participants will be examined for a 15 minute interval with the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. | Participant tolerability of the anti-shock garments |
| Assessment of changes in ejection fraction with and without garment application. | Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. | changes in ejection fraction upon application of anti-shock garment |
Countries
Canada
Outcome results
None listed