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

Primary Purpose

Intubation; Difficult or Failed, Sore-throat, Hoarseness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intubation using C-MAC D blade videolariyngoscope
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intubation; Difficult or Failed focused on measuring Videolaryngoscope,, Intubation, C-MAC R Videolaryngoscope,, D- Blade, Subglottic damage, Postoperative sore throat,, Hoarsness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A : 90 degree

Group B : 80 degree

Group C: 60 degree

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intubation success rate
For evaluation of the success rate modified intubation difficulty score was used.
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

Full Information

First Posted
August 11, 2023
Last Updated
August 21, 2023
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT06011967
Brief Title
Intubation With Different Angles of the Intubation Tube Using C-macr d Blade Videolaringoscope;
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
June 12, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult or Failed, Sore-throat, Hoarseness
Keywords
Videolaryngoscope,, Intubation, C-MAC R Videolaryngoscope,, D- Blade, Subglottic damage, Postoperative sore throat,, Hoarsness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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 angled intubation stylets with C-MAC R videolaryngoscope D- blade.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A : 90 degree
Arm Type
Active Comparator
Arm Description
In this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope
Arm Title
Group B : 80 degree
Arm Type
Active Comparator
Arm Description
In this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope
Arm Title
Group C: 60 degree
Arm Type
Active Comparator
Arm Description
In this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope
Intervention Type
Other
Intervention Name(s)
Intubation using C-MAC D blade videolariyngoscope
Intervention Description
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.
Primary Outcome Measure Information:
Title
sore throat
Description
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
Time Frame
30 minutes, 4 hour, 12 hour, 24 hour
Secondary Outcome Measure Information:
Title
Intubation success rate
Description
For evaluation of the success rate modified intubation difficulty score was used.
Time Frame
2 minutes
Title
Subglottic damage
Description
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
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkım Gizem Yılmaz Selimoğlu
Organizational Affiliation
Yeditepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ferdi Menda, Prof.
Organizational Affiliation
yYeditepe Universitu
Official's Role
Study Director
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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