Remote Ischemic Conditioning
Conditions
Keywords
Remote Ischemic Conditioning, Dynamic Cerebral Autoregulation
Brief summary
The purpose of this study is to determine the impact of serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
Detailed description
Remote ischemic conditioning(RIC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIC provides neuro-protection by means of improving dCA.
Interventions
DEVICEBB-RIC-D1/LAPUL Medical Devices Co, Ltd, China
The RIC consisted of 4 cycles of extremities ischemia (5-minute blood pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm. This intervention was undertaken twice a day for 7 days.
PROCEDUREIntravenous blood collection
Nurses will collect intravenous blood 3ml four times (at baseline and the first, seventh and eighth day of the study).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
DEVICEdCA measurement
Serial measurements of dCA were performed at 10 days, baseline, 1st, 2ed, 4th, 7th, 8th, 10th, 14th, 21th and 35th of the study.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* age from 18 to 50,both genders * willing to participate in follow-up visits
Exclusion criteria
* current or having a history of chronic physical diseases or mental diseases * suffering from infectious diseases in late one month * pregnant and lactating women# * smoking or drinking# * inability to cooperate sufficiently to complete the dCA examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree | 36 days | Dynamic cerebral autoregulation (dCA) is an important indicator of cerebrovascular function which related to the prognosis of cerebrovascular disease. DCA is usually calculated by transfer function analysis. Phase Difference (PD) is gengreated. Low PD at a low frequency band indicates impairment of autoregulation, as it suggests that cerebral blood flow velocity follows the changes in arterial blood pressure with a short delay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg | 36 days | High gain at the same frequency band is also considered an indicator of compromised autoregulation for passively transferring the amplitude of arterial blood pressure to cerebral blood flow velocity. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RIC Group RIC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation).All subjects will take 14 RIC intervention, blood collection and 10 dCA measurements. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | RIC Group | — |
|---|---|---|
| Age, Continuous | 25.73 years STANDARD_DEVIATION 1.78 | — |
| BMI | 20.88 kg/m^2 STANDARD_DEVIATION 2.1 | — |
| Height | 164.50 cm STANDARD_DEVIATION 8.36 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
| Weight | 56.81 kg STANDARD_DEVIATION 9.42 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree
Dynamic cerebral autoregulation (dCA) is an important indicator of cerebrovascular function which related to the prognosis of cerebrovascular disease. DCA is usually calculated by transfer function analysis. Phase Difference (PD) is gengreated. Low PD at a low frequency band indicates impairment of autoregulation, as it suggests that cerebral blood flow velocity follows the changes in arterial blood pressure with a short delay.
Time frame: 36 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RIC Group | Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree | 45.87 degree | Standard Deviation 13.02 |
Secondary
Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg
High gain at the same frequency band is also considered an indicator of compromised autoregulation for passively transferring the amplitude of arterial blood pressure to cerebral blood flow velocity.
Time frame: 36 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RIC Group | Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg | 0.95 cm/s/mmHg | Standard Deviation 0.25 |