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

Sponsor

Yeditepe University (Other)

Overall Status

Completed

CT.gov ID

NCT06011967

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Intubation; Difficult or Failed Sore-throat Hoarseness	Other: Intubation using C-MAC D blade videolariyngoscope	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Mar 15, 2021

Actual Primary Completion Date :

Jun 12, 2022

Actual Study Completion Date :

Jun 13, 2022

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

sore throat [30 minutes, 4 hour, 12 hour, 24 hour]
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

Secondary Outcome Measures

Intubation success rate [2 minutes]
For evaluation of the success rate modified intubation difficulty score was used.
Subglottic damage [2 hours]
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