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

Study Overview
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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.

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.

Official Title
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A Comparative Clinical Trial of a New Rectum Cooling System Versus Temperature-adjusting Blanket on Patients of Hypoxic-ischemic Brain Damage

Conditions
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Hypoxic-Ischemic Encephalopathy

Intervention / Treatment
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* Device: Rectum cooling system
* Device: Hyper-hypothermia blanket


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectum cooling system<br>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. | Device: Rectum cooling system<br> <br> |
| Active Comparator: Hyper-hypothermia blanket<br>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. | Device: Hyper-hypothermia blanket<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cooling | The body temperature is measured every 15 minutes until the target temperature(33-35℃)is reached. | 4 hours | 
| Body Temperature Fluctuations in Maintenance Phase | During the maintenance phase,the body temperature is measured every 15 minutes. | 12 hours | 
| Rate of Rewarming | The body temperature is measured every 15 minutes until it rises to 36.5℃. | 24 to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Complications | Any occurence of shiver，arrhythmia and coagulation abnormalities during the therapy. | 24 to 72 hours | 
| Fecal Occult Blood Testing Results Before and After the Therapy |  | Within 24 hours before the therapy and 48 to 72 hours after the therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Hypothermia, Hypoxic-Ischemic Encephalopathy