Intubation, IntratrachealNCT04116333
Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin
A study testing Endotracheal tube introducer and Macintosh laryngoscope in people with Intubation, Intratracheal and Advanced Cardiac Life Support, run by Derince Training and Research Hospital.
Trial summary
The aim of this study was to compare the impact of using ETI with the Macintosh laryngoscope on first pass success rates of the final year students of medical school on a manikin during continuous chest compressions with mechanical compression device. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation, Intratracheal, Advanced Cardiac Life Support
- What is being tested?
- Endotracheal tube introducer and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2019to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants who want to participate the study
Who cannot join
- Participants who do not want to participate the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin: Randomized, Prospective, Crossover Study
The aim of this study was to compare the impact of using ETI with the Macintosh laryngoscope on first pass success rates of the final year students of medical school on a manikin during continuous chest compressions with mechanical compression device.
Read the detailed description
Fifty-two final year students of Kocaeli University Medical School will participate to the study. The participants will complete the one-hour training lecture on the use of the Macintosh laryngoscope (ML) and the endotracheal tube introducer (ETI) that will be instructed by an emergency medicine specialist. The information section will be followed by a chance of practice each endotracheal intubation method once by using the ML with and without the ETI on the manikin.
Mechanical compression device will be used to perform chest compressions. The manikin will be placed on an ambulance stretcher in a supine position. Airway interventions will be performed in a sitting position on a seat that will be adjusted to the same height with the ambulance seat. The airway kit will be placed beside the head of the manikin.
Each participant will perform 2 airway interventions. Participants will be allowed for maximum 2 attempts for each method. Each procedure will be recorded to the video camera. The participants will be aware of the video camera. Following the interventions each participant will be asked to grade the difficulty of the both methods on a 5-point Likert scale defined as 1: very easy, 2: easy, 3: moderate, 4: difficult and 5: very difficult. The participants will be asked for whether they have prior clinical experience or not with ML or/and ML with ETI use.
- Being tested
- Endotracheal tube introducer, Macintosh laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tube introducerDevice
Use of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.
Macintosh laryngoscopeDevice
Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.
| Study group | Role | What they receive |
|---|---|---|
| ML + ETI | Experimental | Intubation with using endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. Receives: Device: Endotracheal tube introducer; Device: Macintosh laryngoscope |
| ML | Active comparator | Intubation with using the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success
Comparison of the first pass success of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups
Measured: 1 minute
Secondary outcomes (3)
Time to endotracheal intubation
The mean time to successful endotracheal intubation of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups
Measured: 1 minute
Second endotracheal intubation attempt success rates
Second endotracheal intubation attempt success rates of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups
Measured: 1 minute
Difficulty level of each method according to the Likert scale
Grading the difficulty of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer on a 5-point Likert scale
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start9 Oct 2019 (estimated)
- Primary completion10 Oct 2019 (estimated)
- Study completion10 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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
- Model description
- Participants will be randomized to perform either Macintosh laryngoscope or Macintosh laryngoscope with endotracheal tube introducer first, using the envelope method. After completing these initial interventions, they will use the second method.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASIM ENES ÖZBEK, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116333
- Sponsor's protocol ID
- 2019-79
- Status last verified
- Oct 2019
- First submitted
- 25 Sep 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, Sasson C, Crouch A, Perez AB, Merritt R, Kellermann A; Centers for Disease Control and Prevention. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010. MMWR Surveill Summ. 2011 Jul 29;60(8):1-19.
PubMed 21796098Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.
PubMed 26472995Kleinman ME, Perkins GD, Bhanji F, Billi JE, Bray JE, Callaway CW, de Caen A, Finn JC, Hazinski MF, Lim SH, Maconochie I, Nadkarni V, Neumar RW, Nikolaou N, Nolan JP, Reis A, Sierra AF, Singletary EM, Soar J, Stanton D, Travers A, Welsford M, Zideman D. ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement. Circulation. 2018 May 29;137(22):e802-e819. doi: 10.1161/CIR.0000000000000561. Epub 2018 Apr 26.
PubMed 29700123Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
PubMed 26472994Le DH, Reed DB, Weinstein G, Gregory M, Brown LH. Paramedic use of endotracheal tube introducers for the difficult airway. Prehosp Emerg Care. 2001 Apr-Jun;5(2):155-8. doi: 10.1080/10903120190940038.
PubMed 11339725Kovacs G, Law JA, McCrossin C, Vu M, Leblanc D, Gao J. A comparison of a fiberoptic stylet and a bougie as adjuncts to direct laryngoscopy in a manikin-simulated difficult airway. Ann Emerg Med. 2007 Dec;50(6):676-85. doi: 10.1016/j.annemergmed.2007.05.022. Epub 2007 Aug 3.
PubMed 17681639Park L, Zeng I, Brainard A. Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Emerg Med Australas. 2017 Feb;29(1):40-47. doi: 10.1111/1742-6723.12704. Epub 2016 Oct 27.
PubMed 27785883
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin: Randomized, Prospective, Crossover Study
- ClinicalTrials.gov ID
- NCT04116333
- Acronym / sponsor ID
- 2019-79
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 9 Oct 2019 (estimated)
- Primary completion
- 10 Oct 2019 (estimated)
- Study completion
- 10 Oct 2019 (estimated)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare the impact of using ETI with the Macintosh laryngoscope on first pass success rates of the final year students of medical school on a manikin during continuous chest compressions with mechanical compression device.
Detailed description
Fifty-two final year students of Kocaeli University Medical School will participate to the study. The participants will complete the one-hour training lecture on the use of the Macintosh laryngoscope (ML) and the endotracheal tube introducer (ETI) that will be instructed by an emergency medicine specialist. The information section will be followed by a chance of practice each endotracheal intubation method once by using the ML with and without the ETI on the manikin.
Mechanical compression device will be used to perform chest compressions. The manikin will be placed on an ambulance stretcher in a supine position. Airway interventions will be performed in a sitting position on a seat that will be adjusted to the same height with the ambulance seat. The airway kit will be placed beside the head of the manikin.
Each participant will perform 2 airway interventions. Participants will be allowed for maximum 2 attempts for each method. Each procedure will be recorded to the video camera. The participants will be aware of the video camera. Following the interventions each participant will be asked to grade the difficulty of the both methods on a 5-point Likert scale defined as 1: very easy, 2: easy, 3: moderate, 4: difficult and 5: very difficult. The participants will be asked for whether they have prior clinical experience or not with ML or/and ML with ETI use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to perform either Macintosh laryngoscope or Macintosh laryngoscope with endotracheal tube introducer first, using the envelope method. After completing these initial interventions, they will use the second method.
| Arm | Type | Receives |
|---|---|---|
| ML + ETI | Experimental | Device: Endotracheal tube introducer, Device: Macintosh laryngoscopeIntubation with using endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. |
| ML | Active comparator | Device: Macintosh laryngoscopeIntubation with using the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who want to participate the study
Key exclusion criteria (1 listed)
- Participants who do not want to participate the study
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 |
|---|---|---|
| Endotracheal tube introducerUse of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. | Device | ML + ETI |
| Macintosh laryngoscopeUse of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. | Device | ML, ML + ETI |
Primary outcome
First pass success
Time frame: 1 minute
Comparison of the first pass success of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups
3 secondary outcomes
Time to endotracheal intubation
Time frame: 1 minute
Second endotracheal intubation attempt success rates
Time frame: 1 minute
Difficulty level of each method according to the Likert scale
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 21796098McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, Sasson C, Crouch A, Perez AB, Merritt R, Kellermann A; Centers for Disease Control and Prevention. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010. MMWR Surveill Summ. 2011 Jul 29;60(8):1-19.
- Background: PubMed 26472995Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.
- Background: PubMed 29700123Kleinman ME, Perkins GD, Bhanji F, Billi JE, Bray JE, Callaway CW, de Caen A, Finn JC, Hazinski MF, Lim SH, Maconochie I, Nadkarni V, Neumar RW, Nikolaou N, Nolan JP, Reis A, Sierra AF, Singletary EM, Soar J, Stanton D, Travers A, Welsford M, Zideman D. ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement. Circulation. 2018 May 29;137(22):e802-e819. doi: 10.1161/CIR.0000000000000561. Epub 2018 Apr 26.
- Background: PubMed 26472994Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
- Background: PubMed 11339725Le DH, Reed DB, Weinstein G, Gregory M, Brown LH. Paramedic use of endotracheal tube introducers for the difficult airway. Prehosp Emerg Care. 2001 Apr-Jun;5(2):155-8. doi: 10.1080/10903120190940038.
- Background: PubMed 17681639Kovacs G, Law JA, McCrossin C, Vu M, Leblanc D, Gao J. A comparison of a fiberoptic stylet and a bougie as adjuncts to direct laryngoscopy in a manikin-simulated difficult airway. Ann Emerg Med. 2007 Dec;50(6):676-85. doi: 10.1016/j.annemergmed.2007.05.022. Epub 2007 Aug 3.
- Background: PubMed 27785883Park L, Zeng I, Brainard A. Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Emerg Med Australas. 2017 Feb;29(1):40-47. doi: 10.1111/1742-6723.12704. Epub 2016 Oct 27.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tube introducer and Macintosh laryngoscope in people with Intubation, Intratracheal and Advanced Cardiac Life Support, run by Derince Training and Research Hospital.
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: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASIM E OZBEK, M.D. (+1-443-800-0458, drenesozbek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success (time frame: 1 minute). 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 NCT04116333, which also lists 8 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 4 Oct 2019.