ClinicalTrials.gg
CompletedNCT06011967Updated Nov 19, 2024

Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope;

An interventional study of Intubation using C-MAC D blade videolariyngoscope in Intubation; Difficult or Failed, Sore-throat and Hoarseness, sponsored by Yeditepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.

Primary conditionHoarsenessRegistry: PharyngitisReclassifiedWhy we changed it
Registry
Pharyngitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hoarseness
Why
  1. The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Hoarseness.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Yeditepe University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Mar 2021, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.

Read the detailed description

In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. After the approval of the Ethics Committee, patients were randomized into three groups with closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90 degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets. Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure before and after intubation, time from the entrance of the laryngoscope into the mouth to the passage of the vocal cords, time from the appearance of the cords to intubation, Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.

02

Conditions studied

  • Intubation; Difficult or Failed
  • Sore-throat
  • Hoarseness

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Keywords

  • Videolaryngoscope,
  • Intubation
  • C-MAC R Videolaryngoscope,
  • D- Blade
  • Subglottic damage
  • Postoperative sore throat,
  • Hoarsness
03

In context

Hoarseness Reclassified

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

This study's enrollment of 54 is below the median of 108 across 44 interventional studies indexed under Hoarseness.

Browse Hoarseness studies →

Lead sponsor

Yeditepe University is the lead sponsor of 131 studies on the registry; 29 are open to participants now.

Compared within Hoarseness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • I-II
  • Elective operations
  • Supine pozition
  • 18-65 years
  • No history of surgery in the last 6 months
  • No history of airway related surgery
  • No anticipated difficult airway

Exclusion criteria

Exclusion Criteria:

  • Abdomen, thorax, head-neck surgeries
  • Smoker
  • Chronic alcohol abuse
  • Occupational inhaler agent exposure
  • Patients with
  • Patients with a history of radiotheraphy to head-neck region
  • Patients with congenital anomalies at head-neck region
  • Patients with diagnosed abnormalites of head -neck movements
  • Non-cooperatied patients
  • Non-oriented patients
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Group A : 90 degree

    In this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope

    Other: Intubation using C-MAC D blade videolariyngoscope

  • Active comparator
    Group B : 80 degree

    In this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope

    Other: Intubation using C-MAC D blade videolariyngoscope

  • Active comparator
    Group C: 60 degree

    In this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope

    Other: Intubation using C-MAC D blade videolariyngoscope

Interventions

  • OtherIntubation using C-MAC D blade videolariyngoscope

    all patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees.

06

What researchers measure

Primary outcomes

  1. sore throat

    For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe

    Time frame: 30 minutes, 4 hour, 12 hour, 24 hour

Secondary outcomes

  1. Ease of intubation

    For evaluation of the ease of intubation modified intubation difficulty score was used.

    Time frame: 2 minutes

  2. Subglottic damage

    For evaluation of subglottic damage 4-point scaled subglottic damage score was used. grade 0, normal; grade 1, mucosal hyperaemia and oedema and/or slight submucosal haematoma; grade 2, moderately submucosal haematoma; grade 3, mucosal laceration and/or mucosal bleeding

    Time frame: 2 hours

07

Study locations

1 site
  • Yeditepe University
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Jun 2022, 14 months.

Of 21 interventional studies with no phase under Hoarseness, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 14 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2023
First posted
Aug 25, 2023
StartActual
Mar 15, 2021
Primary completionActual
Jun 12, 2022
CompletionActual
Jun 13, 2022
Last update
Nov 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06011967
Responsible party
Sponsor
First posted
Aug 25, 2023
Start date
Mar 15, 2021
Primary completion
Jun 12, 2022
Completion
Jun 13, 2022
Last update
Nov 19, 2024

Study contacts

Alkım Gizem Yılmaz Selimoğlu
principal investigator · Yeditepe University
Ferdi Menda, Prof.
study director · yYeditepe Universitu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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