An interventional study of Rectum cooling system and Hyper-hypothermia blanket in Hypoxic-Ischemic Encephalopathy, sponsored by Children's Hospital of Chongqing Medical University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2017-02-02.
Sponsored by Children's Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
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.
758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.
This study's enrollment of 70 is above the median of 58 across 454 interventional studies indexed under Brain Diseases.
Browse Brain Diseases studies →Children's Hospital of Chongqing Medical University is the lead sponsor of 35 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Rate of Cooling
The body temperature is measured every 15 minutes until the target temperature(33-35℃)is reached.
Time frame: 4 hours
Body Temperature Fluctuations in Maintenance Phase
During the maintenance phase,the body temperature is measured every 15 minutes.
Time frame: 12 hours
Rate of Rewarming
The body temperature is measured every 15 minutes until it rises to 36.5℃.
Time frame: 24 to 48 hours
Incidence of Complications
Any occurence of shiver，arrhythmia and coagulation abnormalities during the therapy.
Time frame: 24 to 72 hours
Fecal Occult Blood Testing Results Before and After the Therapy
Time frame: Within 24 hours before the therapy and 48 to 72 hours after the therapy
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Chongqing Medical University