UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017281 |
|---|---|
| Receipt number | 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 22:28:14 |
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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
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
yokose_p12@ayhoo.co.jp
Sponsor or person
Institute
Yokohama city university school of medicine department of anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019550
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
