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Interim analysis suggested additional enrollment would not change outcomes
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The goal of this study is to compare the first pass success rate of intubation between video assisted intubation and traditional direct visualization intubation in the field by Emergency Medical Service (EMS) professionals
We will equip several local advanced life support ambulances with a low cost video laryngoscope for a total of 12 months. We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods including first pass intubation success, total success rate for intubation, and complications (need for surgical airway, rescue device, need to revert from KVL to DL, etc.). Please see the attached protocol page for additional details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngoscopy | Experimental | We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods. |
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| Direct Laryngoscopy | Active Comparator | We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| King Video Laryngoscope | Device | We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful First Intubation Attempt (First Pass Attempt) | Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube. | less than 24 hours, collected for the duration of the study (approximately 34 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Success | Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated. | up to 24 hours, duration of the study (approximately 34 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Vincent Hospital | Erie | Pennsylvania | 16544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3931512 | Background | Pepe PE, Copass MK, Joyce TH. Prehospital endotracheal intubation: rationale for training emergency medical personnel. Ann Emerg Med. 1985 Nov;14(11):1085-92. doi: 10.1016/s0196-0644(85)80927-6. | |
| 21288624 | Background | Wang HE, Mann NC, Mears G, Jacobson K, Yealy DM. Out-of-hospital airway management in the United States. Resuscitation. 2011 Apr;82(4):378-85. doi: 10.1016/j.resuscitation.2010.12.014. Epub 2011 Feb 1. |
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83 were enrolled and 82 met inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Video Laryngoscopy First Then Direct Laryngoscopy | We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods. King Video Laryngoscope: We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods. |
| FG001 | Direct Laryngoscopy First Then Video Laryngoscopy | We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods. traditional direct laryngoscopy (DL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Initial 6 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Video Laryngoscopy Treatment | Patients treated by ambulance agency with video laryngoscopy. |
| BG001 | Direct Laryngoscopy Treatment | Patients treated by ambulance agency with direct laryngoscopy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful First Intubation Attempt (First Pass Attempt) | Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube. | Posted | Count of Participants | Participants | less than 24 hours, collected for the duration of the study (approximately 34 months) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video Laryngoscopy | Patients treated by an ambulance agency randomized to VL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal Intubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Recognized Esophageal Intubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jestin Carlson | St Vincent Hospital | 8144525000 | jcarlson@svhs.org |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| traditional direct laryngoscopy (DL) | Device |
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| 15271750 | Background | Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15. |
| 11145768 | Background | Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med. 2001 Jan;37(1):32-7. doi: 10.1067/mem.2001.112098. |
| 15175215 | Background | Jones JH, Murphy MP, Dickson RL, Somerville GG, Brizendine EJ. Emergency physician-verified out-of-hospital intubation: miss rates by paramedics. Acad Emerg Med. 2004 Jun;11(6):707-9. doi: 10.1197/j.aem.2003.12.026. |
| 20507222 | Background | Hubble MW, Brown L, Wilfong DA, Hertelendy A, Benner RW, Richards ME. A meta-analysis of prehospital airway control techniques part I: orotracheal and nasotracheal intubation success rates. Prehosp Emerg Care. 2010 Jul-Sep;14(3):377-401. doi: 10.3109/10903121003790173. |
| 16531595 | Background | Wang HE, Yealy DM. How many attempts are required to accomplish out-of-hospital endotracheal intubation? Acad Emerg Med. 2006 Apr;13(4):372-7. doi: 10.1197/j.aem.2005.11.001. Epub 2006 Mar 10. |
| 22325973 | Background | Lossius HM, Roislien J, Lockey DJ. Patient safety in pre-hospital emergency tracheal intubation: a comprehensive meta-analysis of the intubation success rates of EMS providers. Crit Care. 2012 Feb 11;16(1):R24. doi: 10.1186/cc11189. |
| 19947874 | Background | Warner KJ, Carlbom D, Cooke CR, Bulger EM, Copass MK, Sharar SR. Paramedic training for proficient prehospital endotracheal intubation. Prehosp Emerg Care. 2010 Jan-Mar;14(1):103-8. doi: 10.3109/10903120903144858. |
| 22191806 | Background | Carlson JN, Quintero J, Guyette FX, Callaway CW, Menegazzi JJ. Variables associated with successful intubation attempts using video laryngoscopy: a preliminary report in a helicopter emergency medical service. Prehosp Emerg Care. 2012 Apr-Jun;16(2):293-8. doi: 10.3109/10903127.2011.640764. Epub 2011 Dec 22. |
| 23231426 | Background | Guyette FX, Farrell K, Carlson JN, Callaway CW, Phrampus P. Comparison of video laryngoscopy and direct laryngoscopy in a critical care transport service. Prehosp Emerg Care. 2013 Apr-Jun;17(2):149-54. doi: 10.3109/10903127.2012.729128. Epub 2012 Dec 11. |
| 22560464 | Background | Sakles JC, Mosier J, Chiu S, Cosentino M, Kalin L. A comparison of the C-MAC video laryngoscope to the Macintosh direct laryngoscope for intubation in the emergency department. Ann Emerg Med. 2012 Dec;60(6):739-48. doi: 10.1016/j.annemergmed.2012.03.031. Epub 2012 May 5. |
| 21911279 | Background | Mosier JM, Stolz U, Chiu S, Sakles JC. Difficult airway management in the emergency department: GlideScope videolaryngoscopy compared to direct laryngoscopy. J Emerg Med. 2012 Jun;42(6):629-34. doi: 10.1016/j.jemermed.2011.06.007. Epub 2011 Sep 10. |
| 20199237 | Background | Wayne MA, McDonnell M. Comparison of traditional versus video laryngoscopy in out-of-hospital tracheal intubation. Prehosp Emerg Care. 2010 Apr-Jun;14(2):278-82. doi: 10.3109/10903120903537189. |
| 23812581 | Background | Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30. |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Overall Success | Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated. | Posted | Count of Participants | Participants | up to 24 hours, duration of the study (approximately 34 months) |
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| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Direct Laryngoscopy | Patients treated by an ambulance agency randomized to DL | 0 | 42 | 0 | 42 |
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