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Intubation, IntratrachealZVL-DTNCT07873138

A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation

An observational study of Intubation, Intratracheal and Airway Management, run by Nagihan Emiroglu at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Videolaryngoscopy generally improves the glottic view compared with direct laryngoscopy, yet a good view does not always translate into easy delivery of the tracheal tube. Existing classifications describe either the laryngeal view (Cormack-Lehane grade, percentage of glottic opening) or the overall difficulty of… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Videolaryngoscopic tracheal intubation
How many people
250 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2026to 28 Feb 2027
How long will I take part?
1 Day
Phase
Observational

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients scheduled for elective surgery under general anaesthesia requiring tracheal intubation at a single tertiary centre. All patients are intubated with a Macintosh-blade videolaryngoscope by anaesthesiologists as part of routine clinical care. Consecutive eligible patients are enrolled during the study period.

Who may be able to join

  • Age 18 years or older
  • Elective surgery under general anaesthesia requiring tracheal intubation
  • Tracheal intubation planned with a Macintosh-blade videolaryngoscope

Who cannot join

  • Age under 18 years
  • Planned awake intubation or a planned alternative primary airway technique (flexible bronchoscopic intubation, supraglottic airway as the definitive airway)
  • Tracheal intubation performed outside the operating theatre

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gamze Kübra Zelyurt contact

+905544879592

gamzekubra@windowslive.com

Turkey (Türkiye)1 site
  • Sincan Research and Training Hospital

    Ankara, 06932

    Gamze Kübra Zelyurt, +90 5544879592, gamzekubra@windowslive.com

    Nagihan Emiroğlu

Other trials in Turkey (Türkiye)

About this study

Official title: Development and Validation of a Component-Based Score for Characterizing Procedural Difficulty During Videolaryngoscopic Tracheal Intubation: An Observational Study

Videolaryngoscopy generally improves the glottic view compared with direct laryngoscopy, yet a good view does not always translate into easy delivery of the tracheal tube. Existing classifications describe either the laryngeal view (Cormack-Lehane grade, percentage of glottic opening) or the overall difficulty of intubation (Intubation Difficulty Scale), but none characterizes which specific mechanism produces difficulty during videolaryngoscopic intubation.

This observational study evaluates a component-based score developed to describe procedural difficulty encountered during videolaryngoscopic tracheal intubation.

Read more

The score comprises four components, each graded 0 to 2 (total range 0 to 8):

view-tube concordance, restricted epiglottic movement, need for additional laryngoscopic manoeuvres, and need for tube-shaping adjustment.

Adult patients undergoing elective surgery under general anaesthesia with tracheal intubation performed using a Macintosh-blade videolaryngoscope were assessed. The primary objective is to examine the association between the total score and procedural outcomes: intubation time, number of attempts, and first-attempt success. Secondary objectives include the relationship of the score with the Intubation Difficulty Scale, the Video Classification of Intubation, percentage of glottic opening, preoperative airway assessment parameters and operator experience.

Read the detailed description

Videolaryngoscopy improves the glottic view compared with direct laryngoscopy, but an adequate view does not guarantee easy delivery of the tracheal tube into the trachea. Existing classifications address either the laryngeal view (Cormack-Lehane grade, percentage of glottic opening) or the overall difficulty of the intubation episode (Intubation Difficulty Scale). The Video Classification of Intubation records blade type, glottic opening and the ease of tube passage as a descriptive label. None of these tools identifies which specific mechanism produced the difficulty encountered during a videolaryngoscopic intubation.

SCORE UNDER EVALUATION

The score comprises four components, each graded 0, 1 or 2, giving a total range of 0 to 8:

  1. View-tube concordance: whether the tracheal tube can be advanced towards the glottic opening under the obtained view without additional manipulation.
  2. Restricted epiglottic movement: whether epiglottic behaviour interferes with visualisation of the glottic opening.
  3. Need for additional laryngoscopic manoeuvres: whether external laryngeal manipulation, blade repositioning or blade change was required to obtain the view.
  4. Need for tube-shaping adjustment: whether the stylet had to be reshaped or an alternative device such as a bougie was required to direct the tube.

The components were derived from concepts described in the Video Classification of Intubation tube-delivery category and the videolaryngoscopic intubation and difficult airway classification, and were operationalised on a 0 to 2 ordinal scale.

OBJECTIVES

The primary objective is to examine whether the total score is associated with procedural outcomes of the intubation: intubation time, number of attempts and first-attempt success.

Secondary objectives are to examine the relationship of the total score with the Intubation Difficulty Scale, with the Video Classification of Intubation tube delivery category and with the percentage of glottic opening; to examine the association of each individual component with the procedural outcomes; to examine the association of preoperative airway assessment parameters (Mallampati classification, mouth opening, thyromental distance, neck extension, dental prosthesis, upper lip bite test, history of difficult intubation, body mass index) with the total score; and to examine whether operator experience is associated with the score and with the procedural outcomes.

The study does not aim to define a threshold for difficult videolaryngoscopic intubation and does not classify intubations as easy, moderate or difficult. Adult patients undergoing elective surgery under general anaesthesia requiring tracheal intubation will be assessed. All intubations will be performed with a Macintosh-blade videolaryngoscope. For each intubation the four score components, the Intubation Difficulty Scale, the Video Classification of Intubation, the percentage of glottic opening, the Cormack-Lehane grade, preoperative airway assessment parameters, operator experience, intubation time, number of attempts, first-attempt success, need for additional manoeuvres and oxygen desaturation below 90 percent will be recorded.

Continuous variables will be summarised as median with interquartile range. Internal consistency of the score will be assessed with Cronbach's alpha and corrected item-total correlations, and its dimensionality with principal component analysis. Associations will be examined with Spearman rank correlation, Mann-Whitney U and Kruskal-Wallis tests, and with regression models appropriate to the distribution of each outcome.

Being tested
Videolaryngoscopic tracheal intubation
Keywords
tracheal intubation, difficult videolaryngoscopy, airway assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Videolaryngoscopic tracheal intubationOther

    Tracheal intubation performed under videolaryngoscopic guidance with a Macintosh-blade videolaryngoscope as part of routine anaesthetic care. The procedure is observed and scored; it is not assigned by the study protocol.

Study groups in NCT07873138
Study groupRoleWhat they receive
Videolaryngoscopic tracheal intubationAdult patients undergoing elective surgery under general anaesthesia who require tracheal intubation performed with a Macintosh-blade videolaryngoscope. Procedural difficulty is scored with the four-component score at the time of intubation, together with the Intubation Difficulty Scale, the Video Classification of Intubation, percentage of glottic opening and Cormack-Lehane grade. No study-specific intervention is assigned; airway management follows routine clinical practice.
Receives: Other: Videolaryngoscopic tracheal intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association between the total score and intubation time

    Intubation time is defined as the interval in seconds from insertion of the videolaryngoscope blade past the lips until confirmation of tracheal tube placement by capnography. Its association with the total four-component score (range 0 to 8) is assessed using Spearman rank correlation.

    Measured: During the tracheal intubation procedure

  2. Association between the total score and the number of intubation attempts

    The number of intubation attempts is recorded for each patient. An attempt is defined as an effort to advance the tracheal tube towards the glottic opening; repositioning of the blade without advancing the tube is not counted as a separate attempt. The association with the total four-component score (range 0 to 8) is assessed using Spearman rank correlation and ordinal regression.

    Measured: During the tracheal intubation procedure

  3. Association between the total score and first-attempt intubation success

    First-attempt success is defined as correct placement of the tracheal tube within a single intubation attempt. Its association with the total four-component score (range 0 to 8) is assessed using logistic regression with the score entered as a continuous variable.

    Measured: During the tracheal intubation procedure

Secondary outcomes (3)
  1. Association between the total score and the Intubation Difficulty Scale

    The Intubation Difficulty Scale is calculated from its seven components for each intubation. Its association with the total four-component score (range 0 to 8) is assessed using Spearman rank correlation. Partial conceptual overlap between the two instruments is acknowledged and reported.

    Measured: During the tracheal intubation procedure

  2. Association between the total score and the Video Classification of Intubation tube delivery category

    The Video Classification of Intubation records blade type, percentage of glottic opening and the ease of tube delivery as easy, difficult or failed. The distribution of the total four-component score across the easy and difficult categories is compared using the Mann-Whitney U test.

    Measured: During the tracheal intubation procedure

  3. Association between preoperative airway assessment parameters and the total score

    Preoperative airway assessment parameters (Mallampati classification, mouth opening, thyromental distance, neck extension, dental prosthesis, upper lip bite test, history of difficult intubation and body mass index) are examined for their association with the total four-component score using Mann-Whitney U tests and Spearman rank correlation.

    Measured: Preoperative airway assessment and the tracheal intubation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07873138
Sponsor's protocol ID
ZVL-DT-2026-01
Acronym
ZVL-DT
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results, including the four score components, comparator scores and procedural outcome variables, will be made available to qualified researchers upon reasonable request.

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