Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients

NCT06436196 | Not Yet Recruiting

• 1 other identifier: CMH/614
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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. 1.Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.
2. 2.Rate of complications and failed attempts compared between both modalities.

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Outcome Measures

Primary Outcomes (3)

• .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

• 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.

• 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 Outcomes (2)

• Hemodynamic changes at different intervals.

  During attempts to 1 min, 5 min, and 10 min post succesful intubation.

• Hemodynamic changes at different intervals.

  During attempts to 1 min, 5 min, and 10 min post succesful intubation.

Study Arms (2)

Direct Laryngoscopy Group

ACTIVE COMPARATOR

Group of patients in which standard direct laryngoscopy will be used to secure airway.

Device: Direct laryngoscope

Video Laryngoscopy group

ACTIVE COMPARATOR

Group of patients in which Video Laryngoscopy will be used to secure airways.

Device: Video Laryngoscope

Interventions

Video Laryngoscope DEVICE

Use of Video laryngoscope to secure airway

Video Laryngoscopy group

Direct laryngoscope DEVICE

Macintosh or Miller's laryngoscopes used to secure paediatric airways

Direct Laryngoscopy Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Watim Medical & Dental College: lead

Study Sites (1)

Combined Millitary Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 24288617 BACKGROUND

• 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.

  PMID: 27293429 BACKGROUND

• 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.

  PMID: 35497693 BACKGROUND

• 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.

  PMID: 32850555 BACKGROUND

Central Study Contacts

Muhammad Ilyas, FCPS,MBBS

CONTACT

03007355742; med-spec@hotmail.com

Muhammad Munim Ilyas, MBBS

CONTACT

03335642984; munim_95@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of the method which will be used to secure their airway.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Comparitive study between 2 groups.

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Undecided
• Access Criteria: not yet Decided

Locations

PA (1)