NCT07174050

Brief Summary

This study evaluated two different devices used for placing a breathing tube (endotracheal intubation) in adult patients undergoing elective surgery. The aim was to compare the King Vision videolaryngoscope, which has a camera and a guiding channel for the tube, with the traditional Macintosh laryngoscope, which allows doctors to look directly at the vocal cords. The study focused on how long it takes to successfully insert the tube, the need for additional maneuvers during the procedure, and the overall success rate of first attempts. The procedures were performed by novice operators under supervision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 8, 2025

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to successful endotracheal intubation (seconds)

    Measured from insertion of the laryngoscope blade between the patient's incisors until removal of the blade after correct placement of the endotracheal tube, confirmed by capnography.

    During intubation (intraoperative period, approximately 1-2 minutes)

Study Arms (2)

Group K

EXPERIMENTAL

Channelled blade of KVVL

Device: King Vision Channeled Video Laryngoscope

Group M

ACTIVE COMPARATOR

Macintosh laryngoscope

Device: Macintosh Laryngoscopy

Interventions

King Vision Videolaryngoscope (KVVL) is one of the new indirect laryngoscopes with disposable (either with channeled or non-channeled) blades .Both designs include an anti-fog lens coating . The channelled KVVL has a rigid blade with an integrated channel for introducing the endotracheal tube. The height and width of the standard non-channeled and channeled blades are 13 mm and 26 mm vs 18 mm and 29 mm, respectively. The KVVL has a unique design and high-quality image . It has a camera that enables a clear view of the glottis. It is a solid, portable, battery-operated device with an organic LED display for video laryngoscopy . It allows better glottis visualization and Cormack Lehane score than DL. Compared with Airtraq, the KVVL has wide field of view (160° vs 80° respectively) and potentially shortens the time to tracheal intubation .

Group K

In clinical practice, direct laryngoscopy (DL) with either a curved (Macintosh) or straight (Miller) blade is a well-known and reliable technique in the hands of an experienced operator.

Group M

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years old) scheduled for elective surgery under general anesthesia requiring orotracheal intubation
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Mallampati airway classification I-II
  • Written informed consent obtained from the patient

You may not qualify if:

  • Predicted or known difficult airway: Mallampati III-IV, inter-incisor distance \<2.5 cm, thyromental distance \<6 cm, limited cervical spine mobility
  • History of difficult intubation or need for awake/rapid-sequence intubation
  • Upper airway pathology (tumour, trauma, infection), limited mouth opening, or craniofacial anomalies
  • Emergency surgery, high aspiration risk, or full stomach
  • Severe cardiopulmonary instability (e.g., shock, severe hypoxaemia)
  • Pregnancy or breastfeeding
  • BMI \>35 kg/m² (if your protocol excludes obesity; remove if not applicable)
  • Participation refusal or inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir City Hospital

Izmir, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

January 1, 2023

Primary Completion

July 31, 2023

Study Completion

January 1, 2024

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations