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

Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope; Evaluation of the Effect on Post-operative Sore Throat, Ease and Time of Intubation, Hoarseness, Subglottic Damage and Hemodynamic Changes : a Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06011967
Enrollment
54
Registered
2023-08-25
Start date
2021-03-15
Completion date
2022-06-13
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hoarseness, Intubation; Difficult or Failed, Sore-throat

Keywords

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

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.

Interventions

OTHERIntubation 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.

Sponsors

Yeditepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model 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 angled intubation stylets with C-MAC R videolaryngoscope D- blade.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
sore throat30 minutes, 4 hour, 12 hour, 24 hourFor 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

MeasureTime frameDescription
Ease of intubation2 minutesFor evaluation of the ease of intubation modified intubation difficulty score was used.
Subglottic damage2 hoursFor 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026