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

Chongqing Medical University

Status: Completed

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Device: Hyper-hypothermia blanket; Device: Rectum cooling system

Study type: Interventional

Funder types: Other

Identifiers

NCT02544542

X3348

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Rectum cooling system

Experimental group

Description:

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.

Treatment:

Device: Rectum cooling system

Hyper-hypothermia blanket

Active Comparator group

Description:

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.

Treatment:

Device: Hyper-hypothermia blanket