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| ID | Type | Description | Link |
|---|---|---|---|
| Stu08/0041 |
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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.
In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics.
With this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| translaryngeal injection | Active Comparator | translaryngeal injection of local anesthetics before the awake intubation |
|
| spray as you go | Active Comparator | local anesthetics are given through the fiberoptic during awake intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| awake intubation | Procedure | two anesthesia techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pain after anesthesia | Change from Baseline in pain after anesthesia at end of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin R Sablotzki, MD | Clinics of Anesthesiology, Critical care and Pain Therapy | Study Chair |
| Michael Malcharek, MD | Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum St. Georg gGmbH | Leipzig | Saxony | 04129 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26086284 | Derived | Malcharek MJ, Bartz M, Rogos B, Gunther L, Sablotzki A, Gille J, Schneider G. Comparison of Enk Fibreoptic Atomizer with translaryngeal injection for topical anaesthesia for awake fibreoptic intubation in patients at risk of secondary cervical injury: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):615-23. doi: 10.1097/EJA.0000000000000285. |
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