Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery (Laryngoscopy)

Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery: a Randomized Clinical Trial

Background and Objective: Airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia.

Methods: Sixty-six patients were divided into two groups according to the procedure used during intubation, namely, direct laryngoscopy or video laryngoscopy. The Cormack-Lehane and Mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during intubation, mean arterial pressure, EtCO2and SpO2 values were recorded for all the patients.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Desaturation of Blood; Peroperative Complication; Intraoperative Hypertension; Tachycardia, Sinus
• Intervention / Treatment: Device: Laryngoscopy

Detailed Description

Many techniques in the management of a difficult airway have been used in adult patients. In pediatric patients, awake fiberoptic intubation is difficult or even impossible . The video laryngoscope is a new tool produced by combining video technology and laryngoscope. Published studies on the video laryngoscope were mostly performed in adults . In this study, we used a Macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a McGrath video laryngoscope, which is a type of a newly developed video laryngoscope that has not widely been used in the pediatric age group. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. We also evaluated whether Macintosh laryngoscopy and McGrath videolaryngoscopy improved the stress response and whether these approaches facilitated the intubation procedure.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52200
    • Ordu University School of Medicine ,Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study included 66 ASA I-II patients with an age range of 4-13 years and who were scheduled for elective dental surgery under general anesthesia with intubation.

Description

Inclusion Criteria:

Healthy children between the ages of 4-13

• Ordu University School of Medicine ,pediatric age group ,elective oral surgery 4-13 years and who were scheduled for elective oral surgery under general anesthesia with intubation If Patients with a Cormack -Lehane score 1,2 or 3 and if Mallampathy score of 1,2 or 3 were inccluded from the study

Exclusion Criteria:

1. With malignancy disease patients
2. with norological disorders
3. with congenital heart disease
4. with airway abnormality
5. with airway disease patients
6. Patients age Under 4 years , Above 13 years
7. If Patients with a Cormack -Lehane score 4 and if Mallampathy score of 4 were excluded from the study -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group Direct Laringoscopy; Group DL: Group of patients intubated using a Macintoch blade laryngoscope.	Device: Laryngoscopy; During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated
Group Videolaringoscopy; Group VL: Group of patients intubated using a McGrath video laryngoscope.	Device: Laryngoscopy; During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart Rate (HR)	During surgery 0. minute
Heart Rate	Heart Rate (HR)	During surgery 1. minute
Heart Rate	Heart Rate (HR)	During surgery 3. minute
Heart Rate	Heart Rate (HR)	During surgery 5. minute
Heart Rate	Heart Rate (HR)	During surgery 10. minute
Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 0. minute
Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 1. minute
Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 3. minute
Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 5. minute
Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 10. minute
Saturation	SpO2	During surgery 0. minute
Saturation	SpO2	During surgery 1. minute
Saturation	SpO2	During surgery 3. minute
Saturation	SpO2	During surgery 5. minute
Saturation	SpO2	During surgery 10. minute
End Tidal Carbondioxide	EtCO2	During surgery 0. minute
End Tidal Carbondioxide	EtCO2	During surgery 1. minute
End Tidal Carbondioxide	EtCO2	During surgery 3. minute
End Tidal Carbondioxide	EtCO2	During surgery 5. minute
End Tidal Carbondioxide	EtCO2	During surgery 10. minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Entubation Time	Entubation time , (minute)	During Surgery 1.minute
Entubation Time	Entubation time , (minute)	During Surgery 2.minute
Entubation Time	Entubation time , (minute)	During Surgery 3.minute

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Investigators: Principal Investigator: Ebru Canakci, MD, Ordu University School of Medicine Department of Anesthesiology and Reanimation; Study Chair: Ahmet Gultekin, MD, Namık Kemal University School of Medicine Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: video laryngoscopy; direct laryngoscopy; nasotracheal intubation; pediatric oral surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Supraventricular; Tachycardia; Intraoperative Complications; Tachycardia, Sinus
• Other Study ID Numbers: ECanakci

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No