## Protocol Section
### Identification Module
**NCT ID:** NCT06436196

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CMH/614
#### Organization
**Class:** OTHER
**Full Name:** Watim Medical & Dental College
### Status Module
#### Completion Date
**Date:** 2025-01-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Watim Medical & Dental College

#### Responsible Party

**Investigator Affiliation:** Watim Medical & Dental College

**Investigator Full Name:** Muhammad Ilyas

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Endotracheal Tube Wrongly Placed During Anesthetic Procedure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Comparitive study between 2 groups.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Participants are not aware of the method which will be used to secure their airway.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 88

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Direct laryngoscope

**Label:** Direct Laryngoscopy Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Device: Video Laryngoscope

**Label:** Video Laryngoscopy group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Video Laryngoscopy group

**Description:** Use of Video laryngoscope to secure airway

**Name:** Video Laryngoscope

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Direct Laryngoscopy Group

**Description:** Macintosh or Miller's laryngoscopes used to secure paediatric airways

**Name:** Direct laryngoscope

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The time from insertion of laryngoscope in the mouth to the best possible view of the glottis.

**Measure:** .Time taken to acheive the best possible view of the glottis.

**Time Frame:** 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration

**Description:** The time from the insertion of the laryngoscopic blade in the mouth to the correct placement of ETT confirmed by the waveform capnorgraphy.

**Measure:** Time taken to acheive succesful Endotracheal Intubation.

**Time Frame:** 4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.

**Description:** Total No. of attempts(max 3 attempts with the same technique) to secure airway.

**Measure:** No. of Intubation attempts needed

**Time Frame:** 4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.

#### Secondary Outcomes

**Description:** Changes in heart rate will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.

**Measure:** Hemodynamic changes at different intervals.

**Time Frame:** During attempts to 1 min, 5 min, and 10 min post succesful intubation.

**Description:** Changes in blood pressure will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.

**Measure:** Hemodynamic changes at different intervals.

**Time Frame:** During attempts to 1 min, 5 min, and 10 min post succesful intubation.

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 8 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** med-spec@hotmail.com

**Name:** Muhammad Ilyas, FCPS,MBBS

**Phone:** 03007355742

**Role:** CONTACT

**Contact 2:**

**Email:** munim_95@hotmail.com

**Name:** Muhammad Munim Ilyas, MBBS

**Phone:** 03335642984

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rawalpindi

**Contacts:**

***Contact 1:***

- **Email:** munim_95@hotmail.com

- **Name:** Muhammad Munim Ilyas, MBBS

- **Phone:** 03335642984

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** Combined Millitary Hospital

**State:** Punjab

**Zip:** 46000

### IPD Sharing Statement Module

**Access Criteria:** not yet Decided

**Description:** The outcomes of the study will be shared eventually once concluded

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Undecided

### References Module

#### 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.

**PMID:** 24288617

**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.

**PMID:** 27293429

**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.

**PMID:** 35497693

**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.

**PMID:** 32850555

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
