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

Airway Complication of Anesthesia Clinical Trial

— Laryngoscopy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677894
• Other study ID #: ECanakci
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Desaturation of Blood
• Intraoperative Complications
• Intraoperative Hypertension
• Peroperative Complication
• Tachycardia
• Tachycardia, Sinus

Intervention

Device:
• Laryngoscopy
During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated

Locations

Country	Name	City	State
Turkey	Ordu University School of Medicine ,Department of Anesthesiology and Reanimation	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Heart Rate (HR)	During surgery 0. minute
Primary	Heart Rate	Heart Rate (HR)	During surgery 1. minute
Primary	Heart Rate	Heart Rate (HR)	During surgery 3. minute
Primary	Heart Rate	Heart Rate (HR)	During surgery 5. minute
Primary	Heart Rate	Heart Rate (HR)	During surgery 10. minute
Primary	Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 0. minute
Primary	Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 1. minute
Primary	Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 3. minute
Primary	Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 5. minute
Primary	Mean Arterial Pressure	Mean Arterial Pressure (MAP)	During surgery 10. minute
Primary	Saturation	SpO2	During surgery 0. minute
Primary	Saturation	SpO2	During surgery 1. minute
Primary	Saturation	SpO2	During surgery 3. minute
Primary	Saturation	SpO2	During surgery 5. minute
Primary	Saturation	SpO2	During surgery 10. minute
Primary	End Tidal Carbondioxide	EtCO2	During surgery 0. minute
Primary	End Tidal Carbondioxide	EtCO2	During surgery 1. minute
Primary	End Tidal Carbondioxide	EtCO2	During surgery 3. minute
Primary	End Tidal Carbondioxide	EtCO2	During surgery 5. minute
Primary	End Tidal Carbondioxide	EtCO2	During surgery 10. minute
Secondary	Entubation Time	Entubation time , (minute)	During Surgery 1.minute
Secondary	Entubation Time	Entubation time , (minute)	During Surgery 2.minute
Secondary	Entubation Time	Entubation time , (minute)	During Surgery 3.minute