Intubation Clinical Trial
Official title:
Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and "Spray as You go"-Technique
Verified date | April 2015 |
Source | Klinikum St. Georg gGmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
This is a prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.
Status | Completed |
Enrollment | 120 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients with cervical instability undergoing elective decompression of cervical spine Exclusion Criteria: - patient refused participation - contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders) - patient under alcohol or drugs - emergency surgery |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum St. Georg gGmbH | Leipzig | Sachsen |
Lead Sponsor | Collaborator |
---|---|
Klinikum St. Georg gGmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | patients satisfaction with anesthesia | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | up to two weeks after hospital admission | No |
Secondary | pain after anesthesia | Change from Baseline in pain after anesthesia at end of hospital stay | No |
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