UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of McGrath laryngoscope on hemodynamic response during tracheal intubation: a retrospective cohort study
Title of the study (Brief title)	Effect of McGrath laryngoscope on hemodynamic response during tracheal intubation: a retrospective cohort study
Region	Japan

Condition
Condition	Patients who underwent general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this retrospective study was to investigate whether a lower incidence of hypertension after tracheal intubation is observed with the McGRATH laryngoscope compared to that observed using the Macintosh laryngoscope.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Associations between hypertension during intubation and use of the McGrath laryngoscope
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent general anesthesia
Key exclusion criteria	The exclusion criteria included an awake intubation, rapid sequenced induction, nasal intubation, use of the laryngeal mask, use of the intubation devise except Macintosh and McGrath, undergoing cardiovascular and thoracic surgery, and under 18 years old. Patients who had a diagnosis of pheochromocytoma were also excluded.
Target sample size	360

Research contact person
Name of lead principal investigator	Masashi Yokose
Organization	Yokohama city university school of medicine
Division name	Department of anesthesiology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 JAPAN
TEL	045-787-2918
Email	yokose_p12@yahoo.co.jp

Public contact
Name of contact person	Masashi Yokose
Organization	Yokohama city university school of medicine
Division name	Department of anesthesiology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 JAPAN
TEL	045-787-2918
Homepage URL
Email	yokose_p12@ayhoo.co.jp

Sponsor
Institute	Yokohama city university school of medicine department of anesthesiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Yokohama city university school of medicine department of anesthesiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 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
Other related information	The following 18 variables were used as potential predictors: (1) use of the McGRATH laryngoscope, (2) age, (3) gender, (4) body mass index, (5) systolic blood pressure (SBP) on admission (base SBP), (6) diabetes mellitus, (7) estimated glomerular filtration rate (eGFR), (8) current smoking status, (9) ASA-PS, use of (10) atropine and/or (11) vasopressor between the induction of anesthesia and the time of intubation, (12) intubation operator, (13) intubation tube size, (14) time to intubation, (15) Cormack grade, dose of (16) fentanyl, (17) propofol, and/or (18) remifentanil at induction. Logistic regression was used to examine associations between hypertension and the 18 parameters.

Management information
Registered date	2015 Year 04 Month 25 Day
Last modified on	2016 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019550