UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020788
Receipt number R000023233
Scientific Title Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope
Date of disclosure of the study information 2016/01/29
Last modified on 2016/01/29 10:47:06

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Basic information

Public title

Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope

Acronym

Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope

Scientific Title

Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope

Scientific Title:Acronym

Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope

Region

Japan


Condition

Condition

patients scheduled for elective open or laparoscopic abdominal surgery which needs intubation and invasive arterial blood pressure monitoring

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery Obstetrics and Gynecology
Urology Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to compare the response to tracheal intubation between the McGRATH Mac and Macintosh laryngoscope by using invasive blood pressure monitoring.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Systolic blood pressure, diastolic blood pressure and heart rate will be recorded at the following ten time points: 1 ) before the induction of anesthesia, 2 )the time of train-of-four count was zero and the effect-site concentration of fentanyl is maximum level, 3 ) after keeping the laryngscopy for ten seconds, 4 ) immediately after intubation, and 5-9 ) 1, 2, 3, 4 and 5 minutes after intubation, 10 ) the maximum point of the systolic blood pressure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Group G (group of intubation by using McGRATH Mac): n=23

Interventions/Control_2

Group C (group of intubation by using Macintosh laryngoscope): n=23

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients scheduled for elective open or laparoscopic abdominal surgery under general anaesthesia requiring tracheal intubation and invasive blood pressure monitoring

Key exclusion criteria

Patients were excluded if they were suspected to have either conditions or past medical histories below; 1) difficult airway 2) cardiac diseases 3) aortic diseases, 4) cerebrovascular diseases, 5) endocrine diseases with influence on hemodynamic responses 6) morbid obesity.

Target sample size

46


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Kimura

Organization

The Jikei University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

163-1 Kashiwashita, Kashiwa City, Chiba, Japan

TEL

+81-(0)4-7164-1111

Email

travis3939@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Kimura

Organization

The Jikei University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

163-1 Kashiwashita, Kashiwa City, Chiba, Japan

TEL

+81-(0)4-7164-1111

Homepage URL


Email

travis3939@nifty.com


Sponsor or person

Institute

Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

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

2016 Year 01 Month 29 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

Open public recruiting

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 12 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



Management information

Registered date

2016 Year 01 Month 29 Day

Last modified on

2016 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023233


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name