## Protocol Section
### Identification Module
**NCT ID:** NCT03709979

**Brief Title:** Effect Of Position On Laryngeal Visualisation With The C-Mac Videolaryngoscope

**Official Title:** Inönü University Department of Anesthesia

#### Organization Study ID Info
**ID:** C-Mac
#### Organization
**Class:** OTHER
**Full Name:** Inonu University
### Status Module
#### Completion Date
**Date:** 2019-02-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-19

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-02-18

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-21

**Type:** ACTUAL

**Status Verified Date:** 2019-02

#### Study First Post Date
**Date:** 2018-10-17
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-11
**Study First Submit QC Date:** 2018-10-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Inonu University

#### Responsible Party

**Investigator Affiliation:** Inonu University

**Investigator Full Name:** Zekine Begec

**Investigator Title:** 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 aim of this study is to demonstrate the effect of C-Mac videolaryngoscopy with Miller Blade size 0 and 1 on the intubation conditions in children less than 2 years age with a roll inserted under the shoulders.

**Detailed Description:** The laryngoscopic view of the glottis is improved when the angle of the line of vision between the pharyngeal - laryngeal axis and the oral cavity axis is narrow. A roll inserted under the shoulders of the infant will help line up the oral, laryngeal, and pharyngeal axes making direct laryngoscopy easier.

The investigators hypothesized that laryngoscopic view and intubation conditions using C-Mac videolaryngoscope with Miller Blade size 0 and 1 would be better with a roll under shoulder in children under 2 years.

### Conditions Module

**Conditions:**

- Anesthesia

- Intubation

- Laryngoscopy

**Keywords:**

- video laryngoscopy

- Pediatric patient

- Position

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 96

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Children will be intubated by C-MAC videolaryngoscope with placing a folded towel under the shoulder.

**Intervention Names:**

- Device: C-MAC videolaryngoscope

**Label:** C-MAC with folded towel position

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Children will be intubated by C-MAC videolaryngoscope with flat position (non-inserted a folded towel)

**Intervention Names:**

- Device: C-MAC videolaryngoscope

**Label:** C-MAC with flat position

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- C-MAC with flat position

- C-MAC with folded towel position

**Description:** An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope

**Name:** C-MAC videolaryngoscope

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of glottic opening score of 100% denotes visualization of the entire glottis, from the anterior commissure of the vocal cords to the inter-arytenoid notch. If no part of the glottic opening was visualized, the POGO score was recorded as 0%

**Measure:** Percentage of glottic opening score

**Time Frame:** immediately before endotracheal intubation

#### Secondary Outcomes

**Description:** Time to intubation will be measured from the time the videolaryngoscope entered the patient's mouth until the first capnograph trace is seen on the monitor

**Measure:** Time to intubation

**Time Frame:** From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* less than 2 years age undergoing general anaesthesia with tracheal intubation for elective surgery
* American Society of Anesthesiologists' physical status either 1 or 2 are included

Exclusion Criteria:

* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation

**Healthy Volunteers:** True

**Maximum Age:** 24 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Malatya

**Country:** Turkey

**Facility:** Turgut Ozal Medical Center

**Zip:** 44315

#### Overall Officials

**Official 1:**

**Affiliation:** Inonu University Medical Faculty

**Name:** Zekine Begec, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.

**PMID:** 26986776

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-12-21

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 337801

- Type Abbrev: Prot_SAP

- Upload Date: 2019-01-17T05:54

## 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: 2024-05-24
