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Completed

NCT Number: NCT04677894

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

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.

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Key information

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordu University School of Medicine ,Department of Anesthesiology and Reanimation

Ordu, 52200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 -

Treatment and study plan

Laryngoscopy

Device

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

Primary outcomes

  1. Heart Rate

    Time frame: During surgery 0. minute

    Heart Rate (HR)

  2. Heart Rate

    Time frame: During surgery 1. minute

    Heart Rate (HR)

  3. Heart Rate

    Time frame: During surgery 3. minute

    Heart Rate (HR)

  4. Heart Rate

    Time frame: During surgery 5. minute

    Heart Rate (HR)

  5. Heart Rate

    Time frame: During surgery 10. minute

    Heart Rate (HR)

  6. Mean Arterial Pressure

    Time frame: During surgery 0. minute

    Mean Arterial Pressure (MAP)

  7. Mean Arterial Pressure

    Time frame: During surgery 1. minute

    Mean Arterial Pressure (MAP)

  8. Mean Arterial Pressure

    Time frame: During surgery 3. minute

    Mean Arterial Pressure (MAP)

  9. Mean Arterial Pressure

    Time frame: During surgery 5. minute

    Mean Arterial Pressure (MAP)

  10. Mean Arterial Pressure

    Time frame: During surgery 10. minute

    Mean Arterial Pressure (MAP)

  11. Saturation

    Time frame: During surgery 0. minute

    SpO2

  12. Saturation

    Time frame: During surgery 1. minute

    SpO2

  13. Saturation

    Time frame: During surgery 3. minute

    SpO2

  14. Saturation

    Time frame: During surgery 5. minute

    SpO2

  15. Saturation

    Time frame: During surgery 10. minute

    SpO2

  16. End Tidal Carbondioxide

    Time frame: During surgery 0. minute

    EtCO2

  17. End Tidal Carbondioxide

    Time frame: During surgery 1. minute

    EtCO2

  18. End Tidal Carbondioxide

    Time frame: During surgery 3. minute

    EtCO2

  19. End Tidal Carbondioxide

    Time frame: During surgery 5. minute

    EtCO2

  20. End Tidal Carbondioxide

    Time frame: During surgery 10. minute

    EtCO2

Secondary outcomes

  1. Entubation Time

    Time frame: During Surgery 1.minute

    Entubation time , (minute)

  2. Entubation Time

    Time frame: During Surgery 2.minute

    Entubation time , (minute)

  3. Entubation Time

    Time frame: During Surgery 3.minute

    Entubation time , (minute)

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Acronym: Laryngoscopy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2020
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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