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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011375
Receipt No. R000013308
Scientific Title Examination of the intubation tube depth in the general anesthesia in the maxillofacial gery
Date of disclosure of the study information 2013/08/05
Last modified on 2017/01/12

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Basic information
Public title Examination of the intubation tube depth in the general anesthesia in the maxillofacial gery
Acronym Examination of the intubation tube depth
Scientific Title Examination of the intubation tube depth in the general anesthesia in the maxillofacial gery
Scientific Title:Acronym Examination of the intubation tube depth
Region
Japan

Condition
Condition patients for general anesthesia
Classification by specialty
Surgery in general Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 depth of the tube was examined.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Under laryngoscopy, when it was confirmed that the pre-existing marker on the tube had reached the glottis, a mark was made on the tube at the nares. This length was measured as insertion depth using the marker as an index. Next, for insertion depths determined by the CC method, the following measurement was performed. When it was confirmed that the cuff of the tube had passed through the glottis, another measurement was made on the tube at the level of the nares. After the tube was inserted such that 20 mm of the tube above the cuff had passed through the glottis, the cuff of the tube was inflated (cuff pressure 20 cm H2O). The patient's head was placed in the neutral position, following which the tube was further advanced while auscultating bilateral breath sounds with a stethoscope placed on the midaxillary line at the level of the fourth intercostal space, during manual compression of the reservoir bag (airway pressure 15 - 20 cm H2O, tidal volume 400 - 450 mL). When breath sounds from the left side of the chest changed in quality (becoming rough, bubbling, wheezing or bronchial), a mark was made on the tube at the nares. When breath sounds from the left side of the chest disappeared, the tube was withdrawn to the previous position where the change in breath sounds had occurred, and a mark was made on the tube at the nares. At this time, breath sounds from the right side of the chest were examined, and absence of change in the sounds as the tube passed into the left bronchus was confirmed. If there was a sufficient distance between the carina (the point of breath sound change) and glottis, the tube was inserted with the cuff 3.5 cm distal to the glottis, yet proximal to the carina, at which position it was fixed, and a mark was made on the tube at the level of the nares. This length was measured as insertion depth using the CC method.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria General anesthesia patient
Key exclusion criteria Patients with pulmonary diseases, such as bronchial asthma, abnormal breath sounds, and malformations of the trachea, bronchus and lungs on chest radiographs
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Ouchi
Organization Kagoshima University
Division name Anesthesia center
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagoshima University
Division name Anesthesia center
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Kagoshima University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kagoshima University
Organization
Division
Category of Funding Organization
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
2013 Year 08 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
the tube should be inserted 1 cm deeper than that indicated by the marker method
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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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 This work of registry was presented, in part, at the meeting and the article.

Management information
Registered date
2013 Year 08 Month 05 Day
Last modified on
2017 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013308


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