NCT05494463

Brief Summary

The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade to second one and repeat evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,130

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

May 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 6, 2026

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

August 8, 2022

Last Update Submit

January 2, 2026

Conditions

Intubation Complication

Keywords

laryngoscopyendotracheal intubationMiller bladeMacintosh blade

Outcome Measures

Primary Outcomes (1)

  • Number of Grade of view of entrance to larynx

    Laryngoscopy with Macintosh blade and then with Miller blade in the same patient, grade of view estimated in Cormack-lehane scale and POGO - percentage of glottis opening

    immediate

Study Arms (2)

Macintosh blade

NO INTERVENTION

laryngoscopy with Macintosh blade

Miller blade

ACTIVE COMPARATOR

laryngoscopy with Miller blade in the same patient

Device: Miller blade

Interventions

Miller bladeDEVICE

After laryngoscopy with Macintosh blade patient will be evaluated in laryngoscopy with Miller blade

Miller blade

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients scheduled for elective procedures under general anesthesia with endotracheal intubation

You may not qualify if:

  • patients with expected difficutl intubation requiring advanced intubation techniques
  • with injuries of the cervical spine, or for surgery in the cervical spine
  • patients with increased intracranial and intraocular pressure, with vascular changes in the CNS and other parts of the body
  • patients with ASA III and above
  • patients who do not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lodz, Poland

Lodz, 90-153, Poland

Location

Related Publications (1)

  • Ratajczyk P, Kluj P, Szmyd B, Resch J, Hogendorf P, Durczynski A, Gaszynski T. A Comparison of Miller Straight Blade and Macintosh Blade Laryngoscopes for Intubation in Morbidly Obese Patients. J Clin Med. 2024 Jan 24;13(3):681. doi: 10.3390/jcm13030681.

    PMID: 38337375DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: First laryngoscopy with randomly choosed blade and then laryngoscopy wiht second choosen blade in the same patient
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

May 20, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

January 6, 2026

Record last verified: 2022-07

Locations

PL(1)