Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults (RIPCA)
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|ClinicalTrials.gov Identifier: NCT02965547|
Recruitment Status : Unknown
Verified December 2016 by Yi Yang, First Hospital of Jilin University.
Recruitment status was: Not yet recruiting
First Posted : November 16, 2016
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Preconditioning||Device: Remote ischemic conditioning equipment Procedure: Intravenous blood collection Procedure: dCA measurement||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||November 2017|
Experimental: RIPC Group
RIPC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation)
Device: Remote ischemic conditioning equipment
The RIPC 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 and other side thigh. This intervention was undertaken one time in total.
Procedure: Intravenous blood collection
Nurses will collect intravenous blood 6ml twice(at baseline and 1h after RIPC).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
Procedure: dCA measurement
Serial measurements of dCA were performed at 7 time points, baseline, 1h, 3h, 6h, 9h, 12h, 24h after RIPC.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.
- phase difference(PD) in degree [ Time Frame: 2 days ]A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
- the rate of recovery of cerebral blood flow velocity [ Time Frame: 2 days ]
- gain in cm/s/mmHg [ Time Frame: 2 days ]
- resistance index (RI) changes from supine to upright position [ Time Frame: 2 days ]
- pulsatility index (PI) changes from supine to upright position [ Time Frame: 2 days ]
- mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position [ Time Frame: 2 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965547
|Contact: Yi Yang, MD,PhDfirstname.lastname@example.org|
|Contact: Zhenni Guo, MDemail@example.com|