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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.
We hypothesize that intubation is obtained equally effective with both types of flexible scopes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single use flexible optical scope | Active Comparator | Single use flexible optical scope , Ambu aScope |
|
| Multiple use flexible optical scope | Active Comparator | Multiple use flexible optical scope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tracheal intubation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen | Measured during tracheal intubation at induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts at placing the supraglottic-airway-device (SAD) | an attempt is defined as the tip of the SAD passing the upper front teeth | From anesthesia induction and the following 10 minutes during securing of the airway |
| number of attempts at placing the flexible endoscope in the trachea |
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Inclusion Criteria:
ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
The patient must have one or two of the following predictors of difficult tracheal intubation:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael S Kristensen, M.D. | Contact | 0045 35458033 | michael.seltz.kristensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Michael S Kristensen | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Denmark | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| From anesthesia induction and the following 10 minutes |
| number of attempts at intubation | An intubation attempt starts when the tip of the endotracheal tube passes the entrance to the SAD | From anesthesia induction and during the following 10 minutes during airway management |
| Total time for placement of SAD and endoscopy and intubation | During induction of anesthesia and the following 10 minutes during airway management |
| The best glottic view obtained | After anesthesia induction and during the following 10 minutes during airway management |
| The ease of passage of the flexible endoscope via the SAD | During induction and airway management |
| The anesthesiologists' satisfaction with the procedure | During induction of anesthesia and within the 30 minutes hereafter |
| The quality of the endoscopically obtained image | During induction of anesthesia and the following 10 minutes during airway management |
| Postoperative sore throat, dysphonia or dysphagia one hour after extubation | AT the time 1 hour after extubation of the trachea |
| Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre | Not yet recruiting | Strasbourg | 67098 | France |
|