sensory hearing loss
Conditions
Interventions
robotic-assisted group:robotic-assisted electrode insertion
manual group:manual electrode insertion
Sponsors
Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Postlingual deafness patients aged >=6 years, the deafness time is not more than 15 years; or the congenital pre-lingual deafness patients aged 1-6 years; the parental education level of the minors is junior college or above; 2. Suffering from bilateral severe to profound sensorineural hearing loss, hearing aids are ineffective or poorly effective; 3. CT/MRI did not see obvious abnormalities in the inner ear, suitable for unilateral cochlear implants; 4. ASA I to II; 5. No infection and good general condition, laboratory indicators are normal: (1) White blood cell count (4.0 ~ 10.0)x10^9/L; (2) percentage of neutrophils 50-70%; (3) Platelet count (100 ~ 300)x10^9/L; (4) Procalcitonin < 0.5ug/L; (5) The total bilirubin level is within the normal range (3.4 to 17.1 µmol/L); (6) Aspartate aminotransferase / alanine aminotransferase is within 2.5 times normal value (0 ~ 40U / L); (7) Serum creatinine is in the normal range (44-133umol/L).
Exclusion criteria
Exclusion criteria: 1. Previous systemic diseases (heart, nervous system, kidney, liver or coagulation system); 2. The patient currently uses other systemic diseases such as anticoagulant drugs, active or active infections; 3. Allergic to ceftriaxone; 4. Those who did not test according to the requirements of the programme; 5. Patients who refuse to participate for any reason; 6. The operation time of the electrode has been more than 2 hours before the electrode implantation; or other changes in the condition found in the surgery, such as the inability to implant the round window, the discovery of middle ear effusion and mucosal inflammation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| electrode position; | — |
Countries
China
Contacts
Public ContactJia Huan
Department of Otolaryngology, Head & Neck Surgery, Shanghai Ninth People’s Hospital, affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed