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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Saudi Arabia

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.

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 groups in NCT01914523
Study groupRoleWhat they receive
MacintoshPlacebo comparatortracheal intubation will be performed using a Macintosh
Receives: Device: Macintosh
King VisionActive comparatortracheal intubation will be performed using a King Vision
Receives: Device: King Vision
GlidescopeActive comparatortracheal intubation will be performed using a Glidescope
Receives: Device: Glidescope
AirTraqActive comparatortracheal 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted2 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMar 2015
  4. Study completionApr 2015

Resources

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)
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

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.

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