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

NCT04677894 | Completed DMC

• 1 other identifier: ECanakci
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pediatric oral surgery; direct laryngoscopy; video laryngoscopy; nasotracheal intubation

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (3)

• Entubation Time

  During Surgery 1.minute

• Entubation Time

  During Surgery 2.minute

• Entubation Time

  During Surgery 3.minute

Study Arms (2)

Group Direct Laringoscopy

Group DL: Group of patients intubated using a Macintoch blade laryngoscope.

Device: Laryngoscopy

Group Videolaringoscopy

Group VL: Group of patients intubated using a McGrath video laryngoscope.

Device: Laryngoscopy

Interventions

Laryngoscopy DEVICE

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

Group Direct Laringoscopy; Group Videolaringoscopy

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University School of Medicine ,Department of Anesthesiology and Reanimation

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Complications; Tachycardia, Sinus

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Supraventricular; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Ebru Canakci, MD

  Ordu University School of Medicine Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

• Ahmet Gultekin, MD

  Namık Kemal University School of Medicine Department of Anesthesiology and Reanimation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Associated Professor ,Head of Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 21, 2020
• Study Start: November 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)