UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054967
Receipt number R000062807
Scientific Title PREDICTION OF DIFFICULT AIRWAY IN CHIARI TYPE 1 MALFORMATION PATIENTS WITH MRI AND CT SCAN
Date of disclosure of the study information 2024/10/30
Last modified on 2024/07/15 13:55:06

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Basic information

Public title

PREDICTION OF DIFFICULT AIRWAY IN CHIARI TYPE 1 MALFORMATION PATIENTS WITH MRI AND CT SCAN

Acronym

P.D.A.C.T.M.P.M.C.S

Scientific Title

PREDICTION OF DIFFICULT AIRWAY IN CHIARI TYPE 1 MALFORMATION PATIENTS WITH MRI AND CT SCAN

Scientific Title:Acronym

P.D.A.C.T.M.P.M.C.S

Region

Asia(except Japan) Europe


Condition

Condition

Patient studies are done

Classification by specialty

Medicine in general Anesthesiology Neurosurgery
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

With this study we aimed predicting difficult airway among chiari malformation patients with mri and ct scan

Basic objectives2

Others

Basic objectives -Others

With this study we aimed predicting difficult airway among chiari malformation patients with mri and ct scan

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

difficult airway indicators

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Patient with chiari typ 1 malformation

Key exclusion criteria

patients with no mri or ct scan including cervical 6 vertebrea

Target sample size

80


Research contact person

Name of lead principal investigator

1st name FATMA
Middle name YESIM
Last name ABUT

Organization

ISTANBUL TRAINING AND RESEARCH HOSPITAL

Division name

ANESTHESIOLOGY AND REANIMATION

Zip code

34098

Address

CERRAHPASA DISTRICT, ORGENERAL ABDURRAHMAN NAFIZ GURMAN STREET, APARTMENT no.24 ISTANBUL

TEL

+905548845973

Email

anilpalut@hotmail.com


Public contact

Name of contact person

1st name ANIL
Middle name
Last name PALUT KAPTI

Organization

ISTANBUL TRAINING AND RESEARCH HOSPITAL

Division name

ANESTHESIOLOGY AND REANIMATION

Zip code

34098

Address

CERRAHPASA DISTRICT, ORGENERAL ABDURRAHMAN NAFIZ GURMAN STREET, APARTMENT no.24 ISTANBUL

TEL

+905548845973

Homepage URL


Email

anilpalut@hotmail.com


Sponsor or person

Institute

ISTANBUL TRAINING AND RESEARCH HOSPITAL

Institute

Department

Personal name



Funding Source

Organization

ISTANBUL TRAINING AND RESEARCH HOSPITAL

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

ISTANBUL TRAINING AND RESEARCH HOSPITAL

Address

CERRAHPASA DISTRICT, ORGENERAL ABDURRAHMAN NAFIZ GURMAN STREET, APARTMENT no.24 ISTANBUL

Tel

+905548845973

Email

anilpalut@hotmail.com


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

2024 Year 10 Month 30 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

80

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

No longer recruiting

Date of protocol fixation

2023 Year 12 Month 18 Day

Date of IRB

2024 Year 06 Month 13 Day

Anticipated trial start date

2024 Year 06 Month 15 Day

Last follow-up date

2024 Year 07 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In this study we retrospectively calculate difficult airway indications on mri and ct scans on patients with chiari type 1 malformation and control group. As control group we studied on patients with brain tumour. Both groups just included patients who undergoes surgery.


Management information

Registered date

2024 Year 07 Month 15 Day

Last modified on

2024 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062807