CClinicalTrials.gg
CompletedNCT02805569Updated Apr 3, 2018

Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy

An interventional study of articulating stylet and conventional stylet in Difficult Intubation, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-03.

Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators hypothesized that using articulating stylet (AS) would enhance first attempt intubation, shorten the intubation time, reduce the possibility of the soft tissue trauma compared to conventional intubation stylet (IS) in patients with difficult airway .

Read the detailed description

Patients with known airway difficulty (anticipated difficult airway (ADA) score >6) will be included to the study.

All patients will receive general anesthesia for a variety of elective surgical procedure. Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores, Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time, hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.

02

Conditions studied

  • Difficult Intubation

Keywords

  • videolaryngoscope
  • intubation stylet
  • articulating stylet
  • difficult airway
03

In context

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 101 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA 1-2 physical status (Anticipated difficult airway) ADA scores >6 Elective surgery

Exclusion criteria

Exclusion Criteria:

  • ASA 3-4 physical status Immobilizedcervical spine
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
49 participants (actual)

Study arms

  • Active comparator
    Group A

    articulating stylet

    Device: articulating stylet

  • Active comparator
    group C

    conventional stylet

    Device: conventional stylet

Interventions

  • Devicearticulating stylet

    patient who intubated with articulating stylet

  • Deviceconventional stylet

    patient who intubated with conventional stylet

06

What researchers measure

Primary outcomes

  1. intibation time

    Total intubation time (second)

    Time frame: Through intubation completion, an avarage of 5 minutes

Secondary outcomes

  1. tracheal intubation attempts

    number of intubation attempts

    Time frame: Through intubation completion, an avarage of 5 minutes

07

Study locations

1 site
  • Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
    Ankara, 06110, Turkey
08

References and documents

Publications

  • Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005. PubMed 9416711 ↗
  • Suppan L, Tramer MR, Niquille M, Grosgurin O, Marti C. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2016 Jan;116(1):27-36. doi: 10.1093/bja/aev205. Epub 2015 Jun 30. PubMed 26133898 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02805569
Lead sponsor
Diskapi Teaching and Research Hospital
Responsible party
derya özkan (Associated profesor, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Jun 20, 2016
Start date
Jun 2016
Primary completion
Feb 2018
Completion
Feb 2018
Last update
Apr 3, 2018

Study contacts

Derya Özkan, MD
principal investigator · Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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