Oropharyngeal Space in Videolaryngoscopy

April 3, 2014 updated by: Barbe Pieters, Catharina Ziekenhuis Eindhoven

Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade

In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intubation using indirect videolaryngoscopy has many advantages over classic direct laryngoscopy using the Macintosh laryngoscope. There are many different videolaryngoscopes available, and the blade differs largely between videolaryngoscopes. Different size and angles of blades may have an impact on the space available for insertion of the endotracheal tube. The space between the blade and the palatopharyngeal wall may be reduced significantly, so that there is less room in the mouth to insert an endotracheal tube. Positioning and manoeuvring of the endotracheal tube may consequently be more difficult and may traumatize the pharynx as was described in a few case reports, especially when an endotracheal tube with a rigid stylet inserted was used.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
489

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
        • Catharina Ziekenhuis Eindhoven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed patient consent
  • ASA I - III
  • Age > 18 years
  • Elective surgery, other than head and/or neck surgery
  • Pre-operative Mallampati I - III
  • BMI < 35 kg/m2
  • Fasted (≥6 hours)

Exclusion Criteria:

  • No informed patient consent
  • ASA ≥ IV
  • Age < 18 year
  • Emergency surgery, surgery of head and/of neck
  • Locoregional anaesthesia
  • Pre-operative Mallampati IV
  • BMI > 35 kg/m2
  • Fasted < 6 hours
  • Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia)
  • Bad, fragile dentition
  • Dental crowns and/or fixed partial denture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Coopdech® videolaryngoscope
Device: Coopdech® videolaryngoscope
Coopdech® videolaryngoscope
Other Names:
  • Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)
OTHER: C-MAC® videolaryngoscope
Device: C-MAC ® videolaryngoscope
C-MAC ® videolaryngoscope
Other Names:
  • C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
OTHER: McGrath® Series 5 videolaryngoscope
Device: McGrath® Series 5 videolaryngoscope
McGrath® Series 5 videolaryngoscope
Other Names:
  • McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)
OTHER: Glidescope® Cobalt videolaryngoscope
Device: Glidescope® Cobalt videolaryngoscope
Glidescope® Cobalt videolaryngoscope
Other Names:
  • Glidescope® Cobalt (Verathon, Bothell, USA)
OTHER: King Vision® videolaryngoscope
Device: King Vision® videolaryngoscope
King Vision® videolaryngoscope
Other Names:
  • King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)
OTHER: Venner® videolaryngoscope
Device: Venner® videolaryngoscope
Venner® videolaryngoscope
Other Names:
  • Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)
OTHER: McGrath MAC® videolaryngoscope
Device: McGrath® MAC
McGrath® MAC (Aircraft Medical, Edinburgh, UK)
Other Names:
  • McGrath® MAC (Aircraft Medical, Edinburgh, UK)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Palatopharyngeal distance
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Two laryngoscopes (one classic direct laryngoscope and one indirect videolaryngoscope) will subsequently be inserted into the patient's mouth at random order. With each laryngoscope the horizontal distance between the laryngoscope blade and mid-palatopharyngeal fold will be measured using an mm ruler.
Participants will be followed during induction of anesthesia, an expected average of 10 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Investigating how this space differs from the space that remains on the right side of the blade of the classic Macintosh laryngoscope and the palatopharyngeal wall in the same cohort of patients.
Participants will be followed during induction of anesthesia, an expected average of 10 min
Difference in palatopharyngeal distance between videolaryngoscopes
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Comparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.
Participants will be followed during induction of anesthesia, an expected average of 10 min
Cormack-Lehane score
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Registering difficulty of intubation (Cormack-Lehane score)
Participants will be followed during induction of anesthesia, an expected average of 10 min
Successful intubation
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Registering the number of successful intubations.
Participants will be followed during induction of anesthesia, an expected average of 10 min
Use of rigid stylet
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Use of rigid stylet during intubation
Participants will be followed during induction of anesthesia, an expected average of 10 min
Number of attempts
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Number of intubation attempts
Participants will be followed during induction of anesthesia, an expected average of 10 min
Time until picking up endotracheal tube
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Time until picking up endotracheal tube
Participants will be followed during induction of anesthesia, an expected average of 10 min
Epiglottic down-folding
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Occurrence of epiglottic down-folding
Participants will be followed during induction of anesthesia, an expected average of 10 min
Complications
Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Any complication that occurs during intubation will be registered.
Participants will be followed during induction of anesthesia, an expected average of 10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M12-1210 (OTHER: Catharina Ziekenhuis Eindhoven)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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