Intubation With Different Angles of the Intubation Tube Using C-macr d Blade Videolaringoscope;

Intubation; Difficult or Failed Clinical Trial

Official title:

Intubation With Different Angles of the Intubation Tube Using C-macr d Blade Videolaringoscope; Evaluation of the Effect on Intubation Success, Subglotic Damage, and Postoperative Throat Pain: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011967
• Other study ID #: E-66175679-514.04.01-788907
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: August 2023
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study we compared the intubation success, 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.

Description:

In this study we compared the intubation success, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 13, 2022
• Est. primary completion date: June 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hoarseness
• Intubation; Difficult or Failed
• Pharyngitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Yeditepe University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intubation success rate	For evaluation of the success rate modified intubation difficulty score was used.	2 minutes
Secondary	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