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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
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Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx To test the hypothesis that combination of video-laryngoscope with the fiber-optic bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral cavity, pharyngeal or laryngeal pathologies undergoing surgery
Detailed Description:
All subjects consented to this study will require endotracheal intubation. They will be randomly assigned to either one of two groups. The randomization will be stratified on whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization groups are:
When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable blade and a stylet) the procedure sequence is as follows:
When randomized to the "interventional" group. (King Vision video-laryngoscope and #3 disposable blade and the video-bronchoscope (aScope III) The sequence of procedures will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group videolaryngoscope/preformed stylet | Active Comparator | The control group will intubate using the video-laryngoscope / pre formed stylet. Will convert to using video-laryngoscope and fiber-optic bronchoscope (aScope III) if failure to intubate occurs |
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| Interventional Group videolaryngoscope/fibeoptic bronch | Experimental | The interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet | Device | intubation using King Vision video-laryngoscope with #3 disposable blade with stylet convert to intubation with video-laryngoscope and fiber-optic bronchoscope bronchoscope (aScope III) for failure to intubate after three attempts |
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful intubation | measured in seconds | From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion from control group to intervention group | Number of subjects randomized to control group who require to be treated with the method of the intervention group | From the time full relaxation is achieved until the subject is successfully intubated confirmed by breath sounds over a period of up to ten minutes |
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Inclusion Criteria:
Patient will be eligible for the trial if they:
Exclusion Criteria:
Patients will be excluded from the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Lenhardt, MD MBA | University of Louisville 530 South Jackson Street Louisville, KY 40202 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Juneja R, Lacey O. Anaesthesia for head and neck cancer surgery. Curr Anaesth Crit Care 2009;20:28-32. | ||
| 15941739 | Background | Stacey M, Rassam S, Sivasankar R, Hall J. Difficulty in advancing a tracheal tube over a fibreoptic bronchoscope: more solutions. Br J Anaesth. 2005 Jul;95(1):112. doi: 10.1093/bja/aei570. No abstract available. | |
| 12826557 |
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individual patients data will not be shared. Results or the studies findings will be published
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| fiberoptic bronchoscope aScope III | Device | Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III) |
|
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| Number of intubation attempts until successful |
whole numbers of attempts |
| From the time full relaxation is achieved until the time the subject is intubated; confirmed with breath sounds over a period of up to ten minutes |
| Background |
| Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651. |
| 15505482 | Background | Doyle DJ. GlideScope-assisted fiberoptic intubation: a new airway teaching method. Anesthesiology. 2004 Nov;101(5):1252. doi: 10.1097/00000542-200411000-00046. No abstract available. |
| 17975233 | Background | Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792. |
| 19923515 | Background | Turkstra TP, Jones PM, Ower KM, Gros ML. The Flex-It stylet is less effective than a malleable stylet for orotracheal intubation using the GlideScope. Anesth Analg. 2009 Dec;109(6):1856-9. doi: 10.1213/ANE.0b013e3181bc116a. |
| 8467551 | Background | Knill RL. Difficult laryngoscopy made easy with a "BURP". Can J Anaesth. 1993 Mar;40(3):279-82. doi: 10.1007/BF03037041. |
| 6507827 | Background | Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11. |
| 17080693 | Background | Janda M, Scheeren TW, Noldge-Schomburg GF. Management of pulmonary aspiration. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):409-27. doi: 10.1016/j.bpa.2006.02.006. |
| 12067864 | Background | Fasting S, Gisvold SE. Serious intraoperative problems--a five-year review of 83,844 anesthetics. Can J Anaesth. 2002 Jun-Jul;49(6):545-53. doi: 10.1007/BF03017379. |
| 20191780 | Result | Siu LW, Mathieson E, Naik VN, Chandra D, Joo HS. Patient- and operator-related factors associated with successful Glidescope intubations: a prospective observational study in 742 patients. Anaesth Intensive Care. 2010 Jan;38(1):70-5. doi: 10.1177/0310057X1003800113. |
| 19571781 | Result | Van Zundert AA, Hermans B, Kuczkowski KM. Successful use of a videolaryngoscope in a patient with carcinoma of the oropharynx and obstructed airway. Minerva Anestesiol. 2009 Jul-Aug;75(7-8):475-6. No abstract available. |
| 24842175 | Result | Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220. |