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

NCT ID: NCT06011967

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-06-13

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.

Conditions

Intubation; Difficult or Failed; Sore-throat; Hoarseness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group A : 90 degree

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

Group Type: ACTIVE_COMPARATOR

Intubation using C-MAC D blade videolariyngoscope

Intervention Type: 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 B : 80 degree

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

Group Type: ACTIVE_COMPARATOR

Intubation using C-MAC D blade videolariyngoscope

Intervention Type: 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 C: 60 degree

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

Group Type: ACTIVE_COMPARATOR

Intubation using C-MAC D blade videolariyngoscope

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yeditepe University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alkım Gizem Yılmaz Selimoğlu

Role: PRINCIPAL_INVESTIGATOR

Yeditepe University

Ferdi Menda, Prof.

Role: STUDY_DIRECTOR

yYeditepe Universitu

Locations

Yeditepe University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-66175679-514.04.01-788907

Identifier Type: -

Identifier Source: org_study_id