Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients

Endotracheal Tube Wrongly Placed During Anesthetic Procedure Clinical Trial

Official title:

Video Laryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatrics Anesthesia, Comparison of Out-comes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436196
• Other study ID #: CMH/614
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: May 2024
• Source: Watim Medical & Dental College
• Contact: Muhammad Ilyas, FCPS,MBBS
• Phone: 03007355742
• Email: med-spec[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways.

The primary outcome measures include:

1. Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.

2. Rate of complications and failed attempts compared between both modalities.

Description:

The comparision of efficacy of Video Laryngoscopy for pediatric airway vs Direct Laryngoscopy is the goal of this study, Safety of the patients will be the utmost priority with careful case selection alongwith proper informed detailed consent from the guardians of the children.

PROCEDURE:

After induction of General Anesthesia four minutes of proper bag mask ventilation to allow for proper intubating conditions will be done. The time taken from the insertion of the laryngoscopic blade to the best glottic view acheived by the specific technique will be noted seperately and then the time to the succesful acheivement of lung inflation with the proper placement of ETT will be noted seperately, both of these parameters will be recorded.

If in a patient airway is not secured even after 3 attempts by a specific technique the technique would be altered and patient would be excluded from our research.

MATERIALS:

Randomized allotment of patients into the 2 groups i.e Direct Laryngoscopy and Video Laryngoscopy would be done.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• Pediatric patients of age between 2 - 8 years,

• American Society of Anesthesiologist (ASA) grades I-II Children

• Cormack-Lehane grade I, II and III who will need airway management for elective surgery under general anesthesia.

Exclusion Criteria:

• Patients with abnormal airway anatomy,

• Obese patients,

• Emergency surgery,

• Congenital syndrome involving any major organs

• Patients' guardians unwilling to participate .

• Patients in whom airway is not secured with a specific technique even after three attempts.

Related Conditions & MeSH terms

• Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Intervention

Device:
• Video Laryngoscope
Use of Video laryngoscope to secure airway
• Direct laryngoscope
Macintosh or Miller's laryngoscopes used to secure paediatric airways

Locations

Country	Name	City	State
Pakistan	Combined Millitary Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Watim Medical & Dental College

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Myatra SN, Patwa A, Divatia JV. Videolaryngoscopy for all intubations: Is direct laryngoscopy obsolete? Indian J Anaesth. 2022 Mar;66(3):169-173. doi: 10.4103/ija.ija_234_22. Epub 2022 Mar 24. No abstract available. — View Citation

Rabiner JE, Auerbach M, Avner JR, Daswani D, Khine H. Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Intubation of a Pediatric Simulator by Novice Physicians. Emerg Med Int. 2013;2013:407547. doi: 10.1155/2013/407547. Epub 2013 Oct 31. — View Citation

Sinha R, Sharma A, Ray BR, Kumar Pandey R, Darlong V, Punj J, Chandralekha C, Upadhyay AD. Comparison of the Success of Two Techniques for the Endotracheal Intubation with C-MAC Video Laryngoscope Miller Blade in Children: A Prospective Randomized Study. Anesthesiol Res Pract. 2016;2016:4196813. doi: 10.1155/2016/4196813. Epub 2016 May 15. — View Citation

Zhou M, Xi X, Li M, Wang S, Liu Z, Liu JQ. Video Laryngoscopy Improves the Success of Neonatal Tracheal Intubation for Novices but Not for Experienced Medical Staff. Front Pediatr. 2020 Aug 6;8:445. doi: 10.3389/fped.2020.00445. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	.Time taken to acheive the best possible view of the glottis.	The time from insertion of laryngoscope in the mouth to the best possible view of the glottis.	4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
Primary	Time taken to acheive succesful Endotracheal Intubation.	The time from the insertion of the laryngoscopic blade in the mouth to the correct placement of ETT confirmed by the waveform capnorgraphy.	4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
Primary	No. of Intubation attempts needed	Total No. of attempts(max 3 attempts with the same technique) to secure airway.	4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.
Secondary	Hemodynamic changes at different intervals.	Changes in heart rate will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.	During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Secondary	Hemodynamic changes at different intervals.	Changes in blood pressure will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.	During attempts to 1 min, 5 min, and 10 min post succesful intubation.