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

NCT06011967 | Completed

• 1 other identifier: E-66175679-514.04.01-788907
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed; Sore-throat; Hoarseness

Keywords

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

Outcome Measures

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

  30 minutes, 4 hour, 12 hour, 24 hour

Secondary Outcomes (2)

• Ease of intubation

  2 minutes

• Subglottic damage

  2 hours

Study Arms (3)

Group A : 90 degree

ACTIVE COMPARATOR

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

Group B : 80 degree

ACTIVE COMPARATOR

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

Group C: 60 degree

ACTIVE COMPARATOR

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

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.

Group A : 90 degree; Group B : 80 degree; Group C: 60 degree

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pharyngitis; Hoarseness

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Laryngeal Diseases; Respiration Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Alkım Gizem Yılmaz Selimoğlu

  Yeditepe University

  PRINCIPAL INVESTIGATOR

• Ferdi Menda, Prof.

  yYeditepe Universitu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 25, 2023
• Study Start: March 15, 2021
• Primary Completion: June 12, 2022
• Study Completion: June 13, 2022
• Last Updated: November 19, 2024

Record last verified: 2023-08

Locations

TU (1)