Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

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This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.

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Detailed Description

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Mild hypothermia therapy has been proved to be beneficial to patients with severe traumatic brain injury. Currently a variety of cooling methods can achieve mild hypothermia,the hyper-hypothermia blanket being the most widely-used one.

Hyper-hypothermia blanket is a waterbed mattress connected to a thermostat-controlled water tank. Water is cooled in the tank and recycled between the tank and the mattress so that the patients sleeping on the mattress can be stably cooled. The operation is basically program-controlled ,but the whole system is quite expensive.

The investigators came up with a new cooling system which is very simple and accessible. A condom inserted with two 10# gastric tube and one 6# gastric tube and ringed with a rubber band is inserted into the patient's rectum, and ice-cold saline is pumped in through one 10# gastric tube and drained out from the other 10# gastric tube, the 6# gastric tube connected to the pressure monitor. Cooling rate is controlled by the flow speed of cold saline. The investigators will evaluate the effectiveness and safety of this new method for achieving mild hypothermia.

Conditions

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Hypoxic-Ischemic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rectum cooling system

Insert the self-made device into the patient's rectum, pump ice-cold saline in to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by controlling the pumping speed of saline.

Group Type EXPERIMENTAL

Rectum cooling system

Intervention Type DEVICE

Hyper-hypothermia blanket

Let the patient sleep on the hyper-hypothermia blanket, set the target temperature to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by adjusting the target temperature of the device accordingly.

Group Type ACTIVE_COMPARATOR

Hyper-hypothermia blanket

Intervention Type DEVICE

Interventions

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Rectum cooling system

Intervention Type DEVICE

Hyper-hypothermia blanket

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Neonatal HIE
* After cardiopulmonary resuscitation (CPR)
* Severe craniocerebral injury (GCS \< 8)
* Acute central nervous system infection and severe brain edema or lasting convulsion
* Severe cerebral edema caused by various metabolic factors

Exclusion Criteria

* End-stage heart failure
* Uncorrected serious cardiovascular dysfunction
* Active intracranial hemorrhage not under control
* Platelet count \< 50 \* 10\^9 / L

Eligible Sex

ALL

Accepts Healthy Volunteers

No