UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031572
Receipt number R000036048
Scientific Title Glidescope vs Macintosh laryngoscope at hemodynamic response in tracheal intubation: a systematic review and meta-analysis
Date of disclosure of the study information 2018/04/01
Last modified on 2021/09/05 14:38:03

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Basic information

Public title

Glidescope vs Macintosh laryngoscope at hemodynamic response in tracheal intubation: a systematic review and meta-analysis

Acronym

Glidescope vs Macintosh laryngoscope at hemodynamic response

Scientific Title

Glidescope vs Macintosh laryngoscope at hemodynamic response in tracheal intubation: a systematic review and meta-analysis

Scientific Title:Acronym

Glidescope vs Macintosh laryngoscope at hemodynamic response

Region

Japan


Condition

Condition

Patients who need tracheal intubation with Glidescope or macintosh

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether Glidescope attenuate the hemodynamic responses as compared with the Macintosh laryngoscope.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The outcome of this meta-analysis was to determine whether the Glidescope and the Macintosh laryngoscope reduce the hemodynamic responses -heart rate (HR) and mean blood pressure (MBP)-at 60, 120, 180, 300 second (s) after tracheal intubation.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

We searched for all trials that compared measures associated with oral or nasal intubation between use of the Glidescope and use of the Macintosh laryngoscope for direct laryngoscopy in adult patients.

Key exclusion criteria

We excluded the studies that reported the parameters without the hemodynamic changes: i.e. HR and MBP.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Hoshijima

Organization

Saitama Medical University Hospital

Division name

Department of Anesthesiology

Zip code

350-0495

Address

Moroyama, Saitama, 350-0495, Japan

TEL

049-276-1271

Email

hhoshi@saitama-med.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Hoshijima

Organization

Saitama Medical University Hospital

Division name

Department of Anesthesiology

Zip code

350-0495

Address

Moroyama, Saitama, 350-0495, Japan

TEL

049-276-1271

Homepage URL


Email

hhoshi@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University Hospital, Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University Hospital, Department of Anesthesiology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Teikyo University School of Medicine, Yokohama City University Graduate School of Medicine, International University of Health and Welfare

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical University Hospital, Department of Anesthesiology

Address

Moroyama, Saitama, 350-0495, Japan

Tel

049-276-1271

Email

hhoshi@saitama-med.ac.jp


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

2018 Year 04 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_reg_list.cgi

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_reg_list.cgi

Number of participants that the trial has enrolled

634

Results

The literature search identified 13 articles. HR and MBP at 60 s post-intubation was not significantly lower with the GlideScope than with the Macintosh .

Results date posted

2021 Year 09 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We selected articles that included adults who had undergone tracheal intubation (oral or nasal) under general anesthesia. An article comparing HR and MBP measurements recorded before and after tracheal intubation with the GlideScope or Macintosh laryngoscope was included.

Participant flow

We independently assessed each of the two authors to determine if the extracted articles were suitable for our study selection. In addition, disagreements over the interpretation or analysis assignments of the data used in those extracted articles were resolved through discussion. If the results of a report may be duplicated and published, only the report that analyzes the latest data will be added to the meta-analysis. If we found missing or inconsistent data in the extracted articles, we contacted the author directly to retrieve the missing data and resolve the data inconsistencies.

Adverse events

none

Outcome measures

the hemodynamic response, as indicated by HR and MBP at 60 s after tracheal intubation when indirect laryngoscope was performed,

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 01 Month 01 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2019 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 03 Month 05 Day

Last modified on

2021 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036048


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name