UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of video laryngoscopes for tracheal intubation in ER and ICU
Title of the study (Brief title)	Comparison of video laryngoscopes for tracheal intubation in ER and ICU
Region	Japan

Condition
Condition	cases of emergency TI
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	First attempt success rate of tracheal intubation
Key secondary outcomes	Time needed to perform TI Subjective difficulty scale Complications and esophageal intubation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kei Suzuki
Organization	Hiroshima University
Division name	Department of Emergency and Critical Care Medicine
Address	1-2-3Kasumi,Minami-ku,Hiroshima 734-8551 Japan
TEL	0822575456
Email	suzukik@hiroshima-u.ac.jp

Public contact
Name of contact person	Kei Suzuki
Organization	Hiroshima University
Division name	Department of Emergency and Critical Care Medicine
Address	1-2-3Kasumi,Minami-ku,Hiroshima 734-8551 Japan
TEL	0822575456
Homepage URL
Email	suzukik@hiroshima-u.ac.jp

Sponsor
Institute	Department of Emergency and Critical Care Medicine, Hiroshima University
Institute
Department

Funding Source
Organization	Department of Emergency and Critical Care Medicine, Hiroshima University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroshima Prefectural Hospital
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広島大学病院（広島県） 県立広島病院（広島県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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.

Management information
Registered date	2017 Year 06 Month 25 Day
Last modified on	2017 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016182