NCT04566224

Brief Summary

Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2012

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 22, 2020

Last Update Submit

September 22, 2020

Conditions

Intubation;Difficult

Keywords

Intubation rateMacintosh bladeAsian womenintubation difficulty scale

Outcome Measures

Primary Outcomes (5)

  • Intubation time

    Time from laryngoscope insertion to the first adequate lung insufflation

    0-10 minutes during induction

  • Cormack-Lehane grade

    Classification of glottis view during intubation

    0-10 minutes during induction

  • Intubation difficulty scale scores

    Scoring system to assess the difficulty of intubation in each patient

    0-10 minutes during induction

  • Tissue trauma

    Any tissue trauma event related to intubation

    0-10 minutes during induction

  • Teeth trauma

    Any dental damage event related to intubation

    0-10 minutes during induction

Study Arms (2)

Macintosh 2 group

EXPERIMENTAL

Using Macintosh size 2 blade for direct laryngoscope intubation according to randomization

Device: Macintosh size 2 blade

Macintosh 3 group

ACTIVE COMPARATOR

Using Macintosh size 3 blade for direct laryngoscope intubation according to randomization

Device: Macintosh size 3 blade

Interventions

Macintosh size 2 bladeDEVICE

intubate with Macintosh size 2 blade

Macintosh 2 group
Macintosh size 3 bladeDEVICE

intubate with Macintosh size 3 blade

Macintosh 3 group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
  • undergo elective surgery
  • receive endotracheal intubation

You may not qualify if:

  • with known difficult airway (i.e. pathology of the neck, upper airway or alimentary tracts)
  • with risks of pulmonary aspiration (i.e. emergent operation, pregnancy or inadequate nil per os)
  • with previous difficult intubation history
  • intubation attempts more than three times
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (4)

  • Mellick LB, Edholm T, Corbett SW. Pediatric laryngoscope blade size selection using facial landmarks. Pediatr Emerg Care. 2006 Apr;22(4):226-9. doi: 10.1097/01.pec.0000210171.17892.7a.

    PMID: 16651910BACKGROUND

  • Ashfaque M, Mason J, Al-Shaikh B, Adegoke K. A comparison of the Laryngopharyngeal Examination blade and the English Macintosh laryngoscope blade using an intubating manikin: a prospective randomized crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):917-22. doi: 10.1097/EJA.0b013e32832c7848.

    PMID: 19593148BACKGROUND

  • Asai T, Matsumoto S, Fujise K, Johmura S, Shingu K. Comparison of two Macintosh laryngoscope blades in 300 patients. Br J Anaesth. 2003 Apr;90(4):457-60. doi: 10.1093/bja/aeg086.

    PMID: 12644417BACKGROUND

  • Watanabe S, Suga A, Asakura N, Takeshima R, Kimura T, Taguchi N, Kumagai M. Determination of the distance between the laryngoscope blade and the upper incisors during direct laryngoscopy: comparisons of a curved, an angulated straight, and two straight blades. Anesth Analg. 1994 Oct;79(4):638-41. doi: 10.1213/00000539-199410000-00004.

    PMID: 7943768BACKGROUND

Study Officials

  • Nuan-Yen Su, MS

    Mackay Memorial hospital, department of anesthesiology, attending physician

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician, department of anesthesiology

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

June 1, 2011

Primary Completion

May 31, 2012

Study Completion

May 31, 2012

Last Updated

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)