UMIN-CTR Clinical Trial

Public title

Comparison of video laryngoscopes for tracheal intubation in ER and ICU

Acronym

Comparison of video laryngoscopes for tracheal intubation in ER and ICU

Scientific Title

Comparison of video laryngoscopes for tracheal intubation in ER and ICU

Scientific Title:Acronym

Comparison of video laryngoscopes for tracheal intubation in ER and ICU

Region

Japan

Condition

cases of emergency TI

Classification by specialty

Emergency medicine

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the superiority and safety among three video laryngoscopes (Pentax-Airway Scope, King Vison, McGrath MAC) and conventional Macintosh laryngoscope in emergency and critical care setting.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

First attempt success rate of tracheal intubation

Key secondary outcomes

Time needed to perform TI
Subjective difficulty scale
Complications and esophageal intubation

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who required emergency tracheal intubation in the emergency department and intensive care unit with video recording.

Key exclusion criteria

none

Target sample size

280

Name of lead principal investigator

1st name
Middle name
Last name	Kei Suzuki

Organization

Hiroshima University

Division name

Department of Emergency and Critical Care Medicine

Zip code

Address

1-2-3Kasumi,Minami-ku,Hiroshima 734-8551 Japan

TEL

0822575456

Email

suzukik@hiroshima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kei Suzuki

Organization

Hiroshima University

Division name

Department of Emergency and Critical Care Medicine

Zip code

Address

1-2-3Kasumi,Minami-ku,Hiroshima 734-8551 Japan

TEL

0822575456

Homepage URL

Email

suzukik@hiroshima-u.ac.jp

Institute

Department of Emergency and Critical Care Medicine, Hiroshima University

Institute

Department

Personal name

Organization

Department of Emergency and Critical Care Medicine, Hiroshima University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Hiroshima Prefectural Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広島大学病院（広島県） 県立広島病院（広島県）

Date of disclosure of the study information

2017

Year

06

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

287 cases were enrolled. First attempt success rate differed significantly among the 4 laryngoscopes (Pentax-Airway Scope, AWS=78%, King VISION, KV=58%, McGrath MAC, McG=78%, and Macintosh laryngoscope, ML=58%, p=0.004). In post hoc analysis, AWS or McG had higher first attempt success rate compared with KV or ML respectively. In non-experts subgroup, first attempt success rate was differed among 4 laryngoscopes (87%, 50% 78% and 46%, p=0.00004) and AWS or McG had significantly higher first attempt success rate compared with KV or ML respectively, but not in experts subgroup (67% vs 67% vs 78% vs 78%, p=0.556). After adjusting for indications of tracheal intubation, limited mouth opening, restricted neck mobilization, bloods/secretion/vomitus in airway, expert/non-expert, use of AWS (odds ratio 3.422, 95% confidence interval 1.551-7.550, p=0.002) and McG (3.758, 1.640-8.612, p=0.002) were associated with increased odds of first attempt success.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

17

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

There was a significant difference in time needed to perform TI (mean) among 4 laryngoscopes (63, 63, 62 and 52 sec, p=0.043) with no differences detected in post hoc analysis. There was a significant difference in difficulty score (mean) among 4 laryngoscopes (39, 43, 32 and 45, p=0.009) and McG was evaluated as easier than ML in post hoc analysis (p=0.027). There was no difference between 4 laryngoscopes about complications.

Registered date

2017

Year

06

Month

25

Day

Last modified on

2017

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016182