UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011450
Receipt number R000013406
Scientific Title Assessment of Endotracheal Tube Movements with Prone Positioning
Date of disclosure of the study information 2013/08/11
Last modified on 2013/12/24 20:34:59

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Basic information

Public title

Assessment of Endotracheal Tube Movements with Prone Positioning

Acronym

Analysis of Endotracheal Tube Movement with Turning from Supine to Prone

Scientific Title

Assessment of Endotracheal Tube Movements with Prone Positioning

Scientific Title:Acronym

Analysis of Endotracheal Tube Movement with Turning from Supine to Prone

Region

Japan


Condition

Condition

Adult patient with scheduled supine surgery

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reduce airway problems due to endotracheal tube movement from prone positioning

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The distance of three sections from the upper incisor to the (i) carina; (ii) tracheal tube tip; and (iii) vocal cords were measured by bronchofiberscope and analyzed.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects: Grade 1 or 2 Physical Status of the ASA (American Society of Anesthesiologists) of Adult Patients with Scheduled Supine Surgery

Key exclusion criteria

(1)Conscious patients with limited cervical range of motion (2)Patients with prior history of cervical vertebrae surgery (3)Patients with a history of laryngopharynx or lung surgery with possible deformity or degeneration (4)Patients with many missing teeth causing unstable endotracheal tube fixation

Target sample size

38


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nakagawa Kiyotaka

Organization

Kawaguchi Municipal Medical Center

Division name

Department of Anesthesia

Zip code


Address

180 Nishi-Araijyuku, Kawaguchi, Saitama, Japan

TEL

048-287-2525

Email



Public contact

Name of contact person

1st name
Middle name
Last name Nakagawa Kiyotaka

Organization

Kawaguchi Municipal Medical Center

Division name

Department of Anesthesia

Zip code


Address

180 Nishi-Araijyuku, Kawaguchi, Saitama, Japan

TEL

048-287-2525

Homepage URL


Email

matsudanak@yahoo.co.jp


Sponsor or person

Institute

Heiwa Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

平和病院(神奈川県) 
Heiwa Hospital(Kanagawa)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 11 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

Endotracheal tube moved with Postural changes from Supine position to Prone position

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

Terminated

Date of protocol fixation

2012 Year 11 Month 05 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 16 Day

Last follow-up date

2013 Year 03 Month 22 Day

Date of closure to data entry

2013 Year 03 Month 22 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

A non-randomized prospectic study


Management information

Registered date

2013 Year 08 Month 11 Day

Last modified on

2013 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name