Patients Need Tracheal IntubationPhase 1/2NCT01914523
Comparison of the Macintosh, King Vision®, Glidescope® and AirTraq® Laryngoscopes in Routine Airway Management
A Phase 1/2 study testing Macintosh, King Vision and Glidescope in people with Patients Need Tracheal Intubation, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
Trial summary
Failure to successfully intubate the trachea and secure the airway remains a leading cause of morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the concept of endotracheal intubation was developed, 100 years ago the procedure was performed blindly. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Patients Need Tracheal Intubation
- What is being tested?
- Macintosh, King Vision and Glidescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Sep 2013to Apr 2015
- Phase
- Phase 1/2
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status class I-II
- aged 18-65 years
- scheduled for elective surgery
- under general anesthesia
Who cannot join
- Expected or known difficult airway
- history of cervical spine injury
- history of cervical spine surgery
- previous throat surgery
- previous oral surgery
- gastro-esophageal reflux disease
Show all 15Show fewer
- pregnancy
- need for rapid sequence induction
- emergent surgery
- body mass index higher than 35 kg/m2
- Missing incisor teeth
- Unstable hypertension
- Unstable coronary artery disease
- Asthma
- Cerbrovascular disease
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Dammam University
Khobar, Eastern Province, 31259
King Fahd Hospital of the University
Khobar, Eastern Province, 31952
About this study
Failure to successfully intubate the trachea and secure the airway remains a leading cause of morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the concept of endotracheal intubation was developed, 100 years ago the procedure was performed blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view constitutes the main reason for difficult intubations [6].
Video laryngoscopes provide an improved view of the glottis, as the camera is a few millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes has superior glottis view and ease of tracheal intubation compared with the traditional Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer time to tracheal intubation compared with the traditional techniques which be explained with the variable learning curves of the practitioners. [10]
Read more
The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that claim to provide the "perfect view" for intubation via use of video and digital technology.
The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED light source.
Up to best of the authors' knowledge, there is no current published or ongoing randomized controlled comparative study of the use of King Vision laryngoscope with traditional laryngoscope and other video laryngoscopes for endotracheal intubation.
Read the detailed description
Eighty six ASA I-II patients aged 18-65 years scheduled for elective minor surgery under general anesthesia who need tracheal intubation will be included in this prospective, randomized, single-blind, controlled study at the author's center after obtaining approval of the local ethical committee and an informed written consent from all participants.
Patients will be randomly allocated to one of four groups (n=30 for each) namely, Macintosh, King Vision, Glidescope, or AirTraq groups, by drawing sequentially numbered sealed opaque envelopes containing a software-generated randomization code (Random Allocation Software, version 1.0.0, Isfahan University of Medical Sciences, Isfahan, Iran).
Anesthesia:
The Mallampati airway score, thyromental and sternomental distances with neck extension, and the degree of mouth opening will be evaluated preoperatively as factors predicting difficult intubation. Patients' monitoring includes pulse oximetry, noninvasive blood pressure electrocardiography, state and response Entropy (SE and RE) and train of four (TOF) before induction of anesthesia.
The intubators who will participate in the study received a standardized manikin based training course followed by 10 successful intubations in clinical practice with the use of Macintosh, King Vision®, Glidescope®, and the Airtraq® laryngoscopes for endotracheal intubation.
Anesthetic technique will be standardized in all studied. After breathing 100% oxygen for 3 min through a facemask in a supine "sniffing" position, all patients will receive intravenous propofol 2-3 mg/kg and remifentanail 0.05-0.25 µg/kg/min for induction of anesthesia until loss of consciousness defined as decrease of SE less than 50 and the difference between RE and SE is less than 10. Rocrunium 0.6 mg.kg will be administered and complete relaxation will be monitored using a nerve stimulator (TOF-GE, Datex-Ohmeda Division, Instrumentarium Corporation, Helsinki, Finland).
The studied data during intubation will be collected by an independent investigator; the intubator will not informed about the time taken to achieve any intubations. Tracheal intubation will be performed with the Macintosh, King Vision, Glidescope, or AirTraq laryngoscopes, according to the assigned randomization code.
Time to tracheal intubation, defined as the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis, will be determined. The duration of laryngoscopy, defined as the time from holding of the investigated laryngoscope to the appearance of as the first upward deflection on the capnograph, will be recorded.
Before each procedure, the capnograph gas sample delay time will be measured and then subtracted from total recorded duration of laryngoscopy, to correct for the different sampling times between the capnographs used. [11] The best view during laryngoscopy (using Cormack and Lehane classification) will be recorded. [12]
If intubation is unsuccessful at the first attempt, took longer than 120 seconds, or if desaturation noted on the pulse oximeter (defined as SpO2 < 92%) [13], the intubation attempt will be stopped and the lungs will be ventilated with an oxygen-volatile anesthetic mixture for 3 min. A second attempt will be allowed with the randomly allocated airway device. If intubation is unsuccessful after two attempts, the protocol allows intubating the patient with the anesthesiologist's instrument of choice. [14]
The anesthesiologist will be asked to rate the ease of intubation using a 10 cm visual analog scale (0 for much of ease and 10 for extremely difficult). Hemodynamic parameters (heart rate, systolic and mean blood pressures) will be recorded at baseline, during the intubation process, and each 1-min for 5 min and 10 min after tracheal intubation.
A careful examination of the oropharynx will be performed after intubation to determine any lip, dental or mucosal trauma. Following recovery from anesthesia in the post-anesthesia care unit, a trained anesthesiologist who will not be involved in the study and who is blind to the device used will evaluate all patients for a postoperative sore throat to ensure consistency and severity.
Statistical Analysis
Data will be tested for normality using the Kolmogorov-Smirnov test. Serial changes in the studied data at intubation will be analyzed with repeated-measures analysis of variance. Categorical data will be analyzed using Fischer's exact test. Repeated measure analysis of variance (ANOVA) will be used for continuous parametric variables and the differences will be then corrected by post-hoc Bonferoni test. The Kruskal-Wallis one-way ANOVA will be performed for intergroup comparisons for the non-parametric values and post hoc pairwise comparisons will be done using the Wilcoxon rank sum t test. p value < 0.05 will be considered statistically significant.
- Conditions
- Patients Need Tracheal Intubation
- Being tested
- Macintosh, King Vision, Glidescope, AirTraq
- Keywords
- Laryngoscope, Macintosh, Glidescope, King Vision, AirTraq, tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacintoshDevice
Laryngeal exposure and tracheal intubation using that device
King VisionDevice
Laryngeal exposure and tracheal intubation using that device
GlidescopeDevice
Laryngeal exposure and tracheal intubation using that device
AirTraqDevice
Laryngeal exposure and tracheal intubation using that device
| Study group | Role | What they receive |
|---|---|---|
| Macintosh | Placebo comparator | tracheal intubation will be performed using a Macintosh Receives: Device: Macintosh |
| King Vision | Active comparator | tracheal intubation will be performed using a King Vision Receives: Device: King Vision |
| Glidescope | Active comparator | tracheal intubation will be performed using a Glidescope Receives: Device: Glidescope |
| AirTraq | Active comparator | tracheal intubation will be performed using a AirTraq Receives: Device: AirTraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tracheal intubation
the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis
Measured: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
Secondary outcomes (6)
laryngoscopic view
The best view during laryngoscopy (using Cormack and Lehane classification)
Measured: participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds
ease of intubation
using a 10 cm visual analog scale (0 for much of ease and 10 for extremely difficult).
Measured: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
number of intubation attempts
number of intubation attempts
Measured: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
number of optimization maneuvers
If intubation is unsuccessful at the first attempt, took longer than 120 seconds, or if desaturation noted on the pulse oximeter (defined as SpO2 < 92%) [14], the intubation attempt will be stopped and the lungs will be ventilated with an oxygen-volatile anesthetic mixture for 3 min. A second attempt will be allowed with the randomly allocated airway device.
Measured: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
duration of laryngoscopy
the time from holding of the investigated laryngoscope to the appearance of as the first upward deflection on the capnograph
Measured: during laryngoscopy
Hemodynamic parameters
heart rate, systolic and mean blood pressures
Measured: participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Need Tracheal IntubationStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdulmohsen Al Ghamdi, MD, Principal investigator, Associate Professor/Chairman of AnesthesiologyMohamed R El Tahan, MD, Study director, Associate Professor of AnesthesiologyAlaa M Khidr, MD, Study chair, Assistant Professor of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914523
- Sponsor's protocol ID
- KFHU-FBR 0039
- Status last verified
- May 2015
- First submitted
- 28 Jul 2013
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Macintosh, King Vision®, Glidescope® and AirTraq® Laryngoscopes in Routine Airway Management
- ClinicalTrials.gov ID
- NCT01914523
- Acronym / sponsor ID
- KFHU-FBR 0039
- Conditions
- Patients Need Tracheal Intubation
- Keywords
- Laryngoscope, Macintosh, Glidescope, King Vision, AirTraq, tracheal intubation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Aug 2013 (estimated)
- 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.
Failure to successfully intubate the trachea and secure the airway remains a leading cause of morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the concept of endotracheal intubation was developed, 100 years ago the procedure was performed blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view constitutes the main reason for difficult intubations [6].
Video laryngoscopes provide an improved view of the glottis, as the camera is a few millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes has superior glottis view and ease of tracheal intubation compared with the traditional Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer time to tracheal intubation compared with the traditional techniques which be explained with the variable learning curves of the practitioners. [10]
The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that claim to provide the "perfect view" for intubation via use of video and digital technology.
The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED light source.
Up to best of the authors' knowledge, there is no current published or ongoing randomized controlled comparative study of the use of King Vision laryngoscope with traditional laryngoscope and other video laryngoscopes for endotracheal intubation.
Detailed description
Eighty six ASA I-II patients aged 18-65 years scheduled for elective minor surgery under general anesthesia who need tracheal intubation will be included in this prospective, randomized, single-blind, controlled study at the author's center after obtaining approval of the local ethical committee and an informed written consent from all participants.
Patients will be randomly allocated to one of four groups (n=30 for each) namely, Macintosh, King Vision, Glidescope, or AirTraq groups, by drawing sequentially numbered sealed opaque envelopes containing a software-generated randomization code (Random Allocation Software, version 1.0.0, Isfahan University of Medical Sciences, Isfahan, Iran).
Anesthesia:
The Mallampati airway score, thyromental and sternomental distances with neck extension, and the degree of mouth opening will be evaluated preoperatively as factors predicting difficult intubation. Patients' monitoring includes pulse oximetry, noninvasive blood pressure electrocardiography, state and response Entropy (SE and RE) and train of four (TOF) before induction of anesthesia.
The intubators who will participate in the study received a standardized manikin based training course followed by 10 successful intubations in clinical practice with the use of Macintosh, King Vision®, Glidescope®, and the Airtraq® laryngoscopes for endotracheal intubation.
Anesthetic technique will be standardized in all studied. After breathing 100% oxygen for 3 min through a facemask in a supine "sniffing" position, all patients will receive intravenous propofol 2-3 mg/kg and remifentanail 0.05-0.25 µg/kg/min for induction of anesthesia until loss of consciousness defined as decrease of SE less than 50 and the difference between RE and SE is less than 10. Rocrunium 0.6 mg.kg will be administered and complete relaxation will be monitored using a nerve stimulator (TOF-GE, Datex-Ohmeda Division, Instrumentarium Corporation, Helsinki, Finland).
The studied data during intubation will be collected by an independent investigator; the intubator will not informed about the time taken to achieve any intubations. Tracheal intubation will be performed with the Macintosh, King Vision, Glidescope, or AirTraq laryngoscopes, according to the assigned randomization code.
Time to tracheal intubation, defined as the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis, will be determined. The duration of laryngoscopy, defined as the time from holding of the investigated laryngoscope to the appearance of as the first upward deflection on the capnograph, will be recorded.
Before each procedure, the capnograph gas sample delay time will be measured and then subtracted from total recorded duration of laryngoscopy, to correct for the different sampling times between the capnographs used. [11] The best view during laryngoscopy (using Cormack and Lehane classification) will be recorded. [12]
If intubation is unsuccessful at the first attempt, took longer than 120 seconds, or if desaturation noted on the pulse oximeter (defined as SpO2 < 92%) [13], the intubation attempt will be stopped and the lungs will be ventilated with an oxygen-volatile anesthetic mixture for 3 min. A second attempt will be allowed with the randomly allocated airway device. If intubation is unsuccessful after two attempts, the protocol allows intubating the patient with the anesthesiologist's instrument of choice. [14]
The anesthesiologist will be asked to rate the ease of intubation using a 10 cm visual analog scale (0 for much of ease and 10 for extremely difficult). Hemodynamic parameters (heart rate, systolic and mean blood pressures) will be recorded at baseline, during the intubation process, and each 1-min for 5 min and 10 min after tracheal intubation.
A careful examination of the oropharynx will be performed after intubation to determine any lip, dental or mucosal trauma. Following recovery from anesthesia in the post-anesthesia care unit, a trained anesthesiologist who will not be involved in the study and who is blind to the device used will evaluate all patients for a postoperative sore throat to ensure consistency and severity.
Statistical Analysis
Data will be tested for normality using the Kolmogorov-Smirnov test. Serial changes in the studied data at intubation will be analyzed with repeated-measures analysis of variance. Categorical data will be analyzed using Fischer's exact test. Repeated measure analysis of variance (ANOVA) will be used for continuous parametric variables and the differences will be then corrected by post-hoc Bonferoni test. The Kruskal-Wallis one-way ANOVA will be performed for intergroup comparisons for the non-parametric values and post hoc pairwise comparisons will be done using the Wilcoxon rank sum t test. p value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macintosh | Placebo comparator | Device: Macintoshtracheal intubation will be performed using a Macintosh |
| King Vision | Active comparator | Device: King Visiontracheal intubation will be performed using a King Vision |
| Glidescope | Active comparator | Device: Glidescopetracheal intubation will be performed using a Glidescope |
| AirTraq | Active comparator | Device: AirTraqtracheal intubation will be performed using a AirTraq |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists physical status class I-II
- aged 18-65 years
- scheduled for elective surgery
- under general anesthesia
Key exclusion criteria (15 listed)
- Expected or known difficult airway
- history of cervical spine injury
- history of cervical spine surgery
- previous throat surgery
- previous oral surgery
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 |
|---|---|---|
| MacintoshLaryngeal exposure and tracheal intubation using that device | Device | Macintosh |
| King VisionLaryngeal exposure and tracheal intubation using that device | Device | King Vision |
| GlidescopeLaryngeal exposure and tracheal intubation using that device | Device | Glidescope |
| AirTraqLaryngeal exposure and tracheal intubation using that device | Device | AirTraq |
Primary outcome
Time to tracheal intubation
Time frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis
6 secondary outcomes
laryngoscopic view
Time frame: participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds
ease of intubation
Time frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
number of intubation attempts
Time frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
number of optimization maneuvers
Time frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
duration of laryngoscopy
Time frame: during laryngoscopy
Hemodynamic parameters
Time frame: participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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.
Abdulmohsen Al Ghamdi, MD principal investigator
Associate Professor/Chairman of Anesthesiology
Mohamed R El Tahan, MD study director
Associate Professor of Anesthesiology
Alaa M Khidr, MD study chair
Assistant Professor of Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Macintosh, King Vision and Glidescope in people with Patients Need Tracheal Intubation, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to tracheal intubation (time frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2015.