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NCT Number: NCT06011967

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA score 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

  • Abdomen, thorax, head-neck surgeries
  • Smoker
  • Chronic alcohol abuse
  • Occupational inhaler agent exposure
  • Patients with malignancies
  • 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

Treatment and study plan

Intubation using C-MAC D blade videolariyngoscope

Other

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.

Primary outcomes

  1. sore throat

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

    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

Secondary outcomes

  1. Ease of intubation

    Time frame: 2 minutes

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

  2. Subglottic damage

    Time frame: 2 hours

    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

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope; Evaluation of the Effect on Post-operative Sore Throat, Ease and Time of Intubation, Hoarseness, Subglottic Damage and Hemodynamic Changes : a Prospective Randomized Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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