Clinical trial NCT06436196: Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients
Official title: Video Laryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatrics Anesthesia, Comparison of Out-comes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Lead sponsor: Watim Medical & Dental College
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 88
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparitive study between 2 groups.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: .Time taken to acheive the best possible view of the glottis.
timeFrame: 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
measure: Time taken to acheive succesful Endotracheal Intubation.
timeFrame: 4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
measure: No. of Intubation attempts needed
timeFrame: 4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.
Secondary outcomes:
measure: Hemodynamic changes at different intervals.
timeFrame: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
measure: Hemodynamic changes at different intervals.
timeFrame: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Combined Millitary Hospital
state: Punjab
Study officials:
References:
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.
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.
citation: 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.
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.