Safety Study to Evaluate the Effect of Lowering Body Temperature During Cochlear Implantation
Recruitment status was Recruiting
|First Received Date ICMJE||September 11, 2006|
|Last Updated Date||April 19, 2007|
|Start Date ICMJE||March 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00375882 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety Study to Evaluate the Effect of Lowering Body Temperature During Cochlear Implantation|
|Official Title ICMJE||Mild Hypothermia During Cochlear Implantation|
Hypothesis: Mild Hypothermia has a protective effect on residual hearing of patients undergoing cochlear implantation
Hypothermia has been shown to have a protective effect following trauma to the central nervous system and the peripheral auditory system. We have previously demonstrated a protective effect of mild hypothermia on auditory function caused by cochlear implant electrodes in animal models. Preservation of residual hearing of patients undergoing cochlear implantation is highly desirable and based on these animal studies, it may be possible to achieve in human subjects using mild degrees of hypothermia. We propose to investigate the hypothesized protective effect of intra-operative hypothermia on adult subjects undergoing cochlear implantation.
Inclusion Criteria: Adults greater than or equal to 18 years of age with some measurable auditory function who are undergoing cochlear implantation as routine management of severe to profound hearing loss.
Exclusion Criteria: Pure tone average hearing (mean of .5, 1 and 2 KHz) worse than 100dB; Age > 70 years; History of arrhythmia or ischemic heart disease; sickle cell trait or disease; immune incompetence; coagulation disorders; revision cochlear implant; body-mass index > 35; cold related disorders.
Phase I: Up to 40 healthy adult subjects who have qualified for CI will undergo implantation with core body temperature lowered to 34 degree Centigrade for approximately one hour before electrode insertion and 30 minutes after insertion. Otherwise, the surgical technique will be unchanged from our standard procedure.
The heating/cooling blanket is an FDA approved device. similar temperature controlling blankets are used in virtually all operations done under general anesthesia. Each subject's temperature will be gradually lowered only after they are put to sleep. Warming will being at least 30 minutes before the subject is awakened. We will measure and record the subject's temperature every 5 to 15 minutes while they are in the operating room and also while they are in the recovery room.
Each subject will undergo a battery of audiometric tests (CNC words, HINT sentences, pure tone thresholds, and immittance) within one month prior to implantation, at one month post operatively, at 6 months post operatively and 1 year postoperatively. Outcomes will be analyzed by PI after 10 subjects have completed the 1 month test interval. If outcomes indicate proof of principle (measurable pure tone responses in greater than or equal to 60% of subjects), phase two of the study will be initiated. If not, outcomes will be analyzed after 20, 30, and 40 subjects until evidence of hearing conservation or lack of it is established, leading to the following study or precluding it.
Phase II: Up to 80 healthy adults who have qualified for CI will be randomized into control group (CI surgery using standard procedure at core body temperature of 37 degree C) or active group (identical core body temperature of 34 degrees C). Subjects will be randomized using a random table of numbers. The patient, surgeon and audiologist will be blinded to the group assignment. Only the study coordinator will have the sequestered and locked list of randomization and blinding. Only the anesthesiologist will know the patients' assignment at the time of surgery. The audiologist will not be present in the O.R. or in the outpatient clinic, but will only test the patient post surgery. Each subject will undergo a battery of audiometric tests (CNC words, HINT sentences, pure tone thresholds, and immittance) just prior to implantation, at 1 month post operatively, at 6 months post operatively and at 1 year postoperatively.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: hypothermia|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Completion Date||March 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00375882|
|Other Study ID Numbers ICMJE||001|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Miami|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Miami|
|Verification Date||April 2007|
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