Clinical trial NCT04677894: Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery
Official title: Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery: a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Peroperative Complication
Intraoperative Hypertension
Tachycardia, Sinus
Desaturation of Blood
Keywords: pediatric oral surgery
direct laryngoscopy
video laryngoscopy
nasotracheal intubation
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Heart Rate
timeFrame: During surgery 0. minute
measure: Heart Rate
timeFrame: During surgery 1. minute
measure: Heart Rate
timeFrame: During surgery 3. minute
measure: Heart Rate
timeFrame: During surgery 5. minute
measure: Heart Rate
timeFrame: During surgery 10. minute
measure: Mean Arterial Pressure
timeFrame: During surgery 0. minute
measure: Mean Arterial Pressure
timeFrame: During surgery 1. minute
measure: Mean Arterial Pressure
timeFrame: During surgery 3. minute
measure: Mean Arterial Pressure
timeFrame: During surgery 5. minute
measure: Mean Arterial Pressure
timeFrame: During surgery 10. minute
measure: Saturation
timeFrame: During surgery 0. minute
measure: Saturation
timeFrame: During surgery 1. minute
measure: Saturation
timeFrame: During surgery 3. minute
measure: Saturation
timeFrame: During surgery 5. minute
measure: Saturation
timeFrame: During surgery 10. minute
measure: End Tidal Carbondioxide
timeFrame: During surgery 0. minute
measure: End Tidal Carbondioxide
timeFrame: During surgery 1. minute
measure: End Tidal Carbondioxide
timeFrame: During surgery 3. minute
measure: End Tidal Carbondioxide
timeFrame: During surgery 5. minute
measure: End Tidal Carbondioxide
timeFrame: During surgery 10. minute
Secondary outcomes:
measure: Entubation Time
timeFrame: During Surgery 1.minute
measure: Entubation Time
timeFrame: During Surgery 2.minute
measure: Entubation Time
timeFrame: During Surgery 3.minute
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University School of Medicine ,Department of Anesthesiology and Reanimation
Study officials:
affiliation: Ordu University School of Medicine Department of Anesthesiology and Reanimation
name: Ebru Canakci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Namık Kemal University School of Medicine Department of Anesthesiology and Reanimation
name: Ahmet Gultekin, MD
role: STUDY_CHAIR
References: