Adult
Conditions
Keywords
adult, remote ischemic conditioning, high altitude condition, cognitive function, blood oxygen levels
Brief summary
Several studies have shown cognitive impairment such as memory, perception and learning skill during ascent to high altitudes. However, few studies have directly investigated the effect of high altitudes exposure on attention-a high-level cognitive function. Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, It has been proven to be an effective strategy for neuroprotection in ischemic stroke and chronic cerebral ischemia patients.
Detailed description
This study will provide insights into the preliminary proof of principle, safety, cognitive dysfunction and blood oxygen levels protective effects of RIC in Adults Exposing to High Altitude Conditions, and this data will provide parameters for future larger scale clinical trials if efficacious.
Interventions
DEVICERIC
Adults allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
DEVICEsham RIC
Adults allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
Sponsors
Xuanwu Hospital, Beijing
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* The age was between 19 and 30 years. * All participants should meet the criteria which included right-hand dominance, normal or corrected-to-normal vision. * the RIC group volunteers have no history of intravascular thrombosis in the bilateral upper limbs; * The high altitude participants move into the high-altitude environment within one month, and the low altitude volunteers have long-term life in low altitude areas.
Exclusion criteria
* Severe hepatic or renal dysfunction * Severe hemostatic disorder or severe coagulation dysfunction * Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation * Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year * Patient participating in a study involving other drug or device trial study 7. Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations 8. Unlikely to be available for follow-up for 3 months 9. Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attentional network test | change from baseline (pre-RIC treatment) at 7days after RIC treatment | The computer software attentional network test (ANT) as described by Fan et al. in 2002 will be used to measuring the Orienting function, executive function and alerting function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| basic fibroblast growth factor | change from baseline (pre-RIC treatment) at 7 days after RIC treatment | basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers. |
| platelet derived growth factor | change from baseline (pre-RIC treatment) at 7 days after RIC treatment | platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers. |
| vascular endothelial growth factor | change from baseline (pre-RIC treatment) at 7 days after RIC treatment | vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers. |
| distal radial pulses | within 7 days after RIC treatment | It is an aspect which can reflect the safety of remote ischemic conditioning |
| the number of erythema in the skin | within 7 days after RIC treatment | It is an aspect which can reflect the safety of remote ischemic conditioning |
| the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure | within 7 days after RIC treatment | it is an aspect which can reflect the safety of remote ischemic conditioning |
| the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator. | within 7 days after RIC treatment | it is an aspect which can reflect the safety of remote ischemic conditioning |
| heart rate | change from baseline(pre-RIC treatment) at 7days after RIC treatment | the heart rate will be measured by automatic blood pressure monitor |
| the rate of Adverse event | change from baseline (pre-RIC treatment) at 7 days after RIC treatment | Any adverse event will be reported and its relationship with the RIC intervention will be evaluated. |
| blood oxygen saturation (SaO2) | change from baseline(pre-RIC treatment) at 7days after RIC treatment | The portable oxygen saturation ward apparatus (Datex -Ohmeda, USA) will be used to monitor the blood oxygen saturation (SaO2) |
| cerebral oxygen saturation(TOI) | change from baseline(pre-RIC treatment) at 7days after RIC treatment | The cerebral oxygen monitor (EGOS-600, Jiangsu China) will be used to monitor the cerebral oxygen saturation (TOI). |
| The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA) | change from baseline(pre-RIC treatment) at 7days after RIC treatment | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards |
| end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA) | change from baseline(pre-RIC treatment) at 7days after RIC treatment | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards |
| the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA) | change from baseline (pre-RIC treatment) at 7 days after RIC treatment | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards |
| pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA) | change from baseline (pre-RIC treatment) at 7 days after RIC treatment | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards |
| The degree of palpation of tenderness--visual analogue scale | within 7 days after RIC treatment | The degree of palpation of tenderness is an aspect which can reflect the safety of remote ischemic conditioning. The pain was assessed with visual analogue scale ( VAS) |
| the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator | within 7 days after RIC treatment | it is an aspect which can reflect the safety of remote ischemic conditioning |
| blood pressure | change from baseline(pre-RIC treatment) at 7days after RIC treatment | Both systolic, and diastolic pressure will be measured by automatic blood pressure monitor |
Contacts
Primary ContactLian Duan, MD PHD
Backup ContactHan Cong, MD MS
Outcome results
None listed