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Completed

NCT Number: NCT02965547

Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults

The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

Remote ischemic preconditioning(RIPC) 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 RIPC provides neuro-protection by means of improving dCA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 70,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

Treatment and study plan

Remote ischemic conditioning equipment

Device

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.

Intravenous blood collection

Procedure

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.

dCA measurement

Procedure

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.

Primary outcomes

  1. 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.

  2. the rate of recovery of cerebral blood flow velocity

    Time frame: 2 days

  3. gain in cm/s/mmHg

    Time frame: 2 days

Secondary outcomes

  1. resistance index (RI) changes from supine to upright position

    Time frame: 2 days

  2. pulsatility index (PI) changes from supine to upright position

    Time frame: 2 days

  3. mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Acronym: RIPCA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 16, 2016
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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