Clinical trial NCT06011967: Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope;
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Sore-throat
Hoarseness
Keywords: Videolaryngoscope,
Intubation
C-MAC R Videolaryngoscope,
D- Blade
Subglottic damage
Postoperative sore throat,
Hoarsness
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 angled intubation stylets with C-MAC R videolaryngoscope D- blade.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: sore throat
timeFrame: 30 minutes, 4 hour, 12 hour, 24 hour
Secondary outcomes:
measure: Ease of intubation
timeFrame: 2 minutes
measure: Subglottic damage
timeFrame: 2 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Yeditepe University
name: Alkım Gizem Yılmaz Selimoğlu
role: PRINCIPAL_INVESTIGATOR
affiliation: yYeditepe Universitu
name: Ferdi Menda, Prof.
role: STUDY_DIRECTOR
References: