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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017281
Receipt No. R000019550
Scientific Title Effect of McGrath laryngoscope on hemodynamic response during tracheal intubation: a retrospective cohort study
Date of disclosure of the study information 2015/04/26
Last modified on 2016/06/06

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Basic information
Public title Effect of McGrath laryngoscope on hemodynamic response during tracheal intubation: a retrospective cohort study
Acronym Effect of McGrath laryngoscope on hemodynamic response during tracheal intubation: a retrospective cohort study
Scientific Title Effect of McGrath laryngoscope on hemodynamic response during tracheal intubation: a retrospective cohort study
Scientific Title:Acronym 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

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
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
1st name
Middle name
Last name Masashi Yokose
Organization Yokohama city university school of medicine
Division name Department of anesthesiology
Zip code
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
1st name
Middle name
Last name Masashi Yokose
Organization Yokohama city university school of medicine
Division name Department of anesthesiology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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