Respiratory FailureNCT02208349
King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial
A study testing King Video Laryngoscope and traditional direct laryngoscopy (DL) in people with Respiratory Failure, run by Saint Vincent Hospital, Pennsylvania at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- King Video Laryngoscope and traditional direct laryngoscopy (DL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients >= age 18 year of age undergoing ETI in the prehospital setting
Who cannot join
- age < 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Conditions
- Respiratory Failure
- Being tested
- King Video Laryngoscope, traditional direct laryngoscopy (DL)
- Keywords
- intubation, laryngoscopy, prehospital, emergency medical services
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Video LaryngoscopeDevice
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)Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: King Video Laryngoscope |
| 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. Receives: Device: traditional direct laryngoscopy (DL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: less than 24 hours, collected for the duration of the study (approximately 34 months)
Secondary outcomes (1)
Overall Success
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.
Measured: up to 24 hours, duration of the study (approximately 34 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionApr 2017
Why it stopped: Interim analysis suggested additional enrollment would not change outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Vincent Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208349
- Sponsor's protocol ID
- LECOM Research Grant 2013
- Status last verified
- Jun 2018
- First submitted
- 18 Mar 2014
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 3931512Wang 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.
PubMed 21288624Mort 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.
PubMed 15271750Katz 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.
PubMed 11145768Jones 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.
PubMed 15175215Hubble 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.
PubMed 20507222Wang 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.
PubMed 16531595Lossius 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.
PubMed 22325973Warner 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.
PubMed 19947874Carlson 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.
PubMed 22191806Guyette 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.
PubMed 23231426Sakles 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.
PubMed 22560464Mosier 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.
PubMed 21911279Wayne 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.
PubMed 20199237Akihisa 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.
PubMed 23812581
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02208349
- Acronym / sponsor ID
- LECOM Research Grant 2013
- Conditions
- Respiratory Failure
- Keywords
- intubation, laryngoscopy, prehospital, emergency medical services
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis suggested additional enrollment would not change outcomes
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Saint Vincent Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngoscopy | Experimental | Device: King Video LaryngoscopeWe 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. |
| Direct Laryngoscopy | Active comparator | Device: traditional direct laryngoscopy (DL)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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients >= age 18 year of age undergoing ETI in the prehospital setting
Key exclusion criteria (1 listed)
- age < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| King Video LaryngoscopeWe 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. | Device | Video Laryngoscopy |
| traditional direct laryngoscopy (DL) | Device | Direct Laryngoscopy |
Primary outcome
Number of Participants With Successful First Intubation Attempt (First Pass Attempt)
Time frame: less than 24 hours, collected for the duration of the study (approximately 34 months)
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.
1 secondary outcome
Overall Success
Time frame: up to 24 hours, duration of the study (approximately 34 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3931512Pepe 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.
- Background: PubMed 21288624Wang 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.
- Background: PubMed 15271750Mort 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.
- Background: PubMed 11145768Katz 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.
- Background: PubMed 15175215Jones 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.
- Background: PubMed 20507222Hubble 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.
- Background: PubMed 16531595Wang 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.
- Background: PubMed 22325973Lossius 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.
- Background: PubMed 19947874Warner 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.
- Background: PubMed 22191806Carlson 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.
- Background: PubMed 23231426Guyette 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.
- Background: PubMed 22560464Sakles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King Video Laryngoscope and traditional direct laryngoscopy (DL) in people with Respiratory Failure, run by Saint Vincent Hospital, Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful First Intubation Attempt (First Pass Attempt) (time frame: less than 24 hours, collected for the duration of the study (approximately 34 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02208349, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.