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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed; Hoarseness; Sore-throat
• Intervention / Treatment: Other: Intubation using C-MAC D blade videolariyngoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Yeditepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 minutes, 4 hour, 12 hour, 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours
Ease of intubation	For evaluation of the ease of intubation modified intubation difficulty score was used.	2 minutes

Collaborators and Investigators

• Sponsor: Yeditepe University
• Investigators: Principal Investigator: Alkım Gizem Yılmaz Selimoğlu, Yeditepe University; Study Director: Ferdi Menda, Prof., yYeditepe Universitu

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): June 12, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Intubation; Videolaryngoscope,; C-MAC R Videolaryngoscope,; D- Blade; Subglottic damage; Postoperative sore throat,; Hoarsness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Pharyngeal Diseases; Laryngeal Diseases; Voice Disorders; Dysphonia; Hoarseness; Pharyngitis
• Other Study ID Numbers: E-66175679-514.04.01-788907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No