UMIN-CTR Clinical Trial

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

patients for general anesthesia

Classification by specialty

Surgery in general	Anesthesiology	Oral surgery

Classification by malignancy

Others

Genomic information

NO

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

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 When breath sounds from the left side of the chest disappeared, the tube was withdrawn to the previous position where the change in breath sounds had occurred, and a mark was made on the tube at the nares.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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kagoshima University

Institute

Department

Personal name

Organization

Kagoshima University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

08

Month

05

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

This work of registry was presented, in part, at the meeting and the article.

Registered date

2013

Year

08

Month

05

Day

Last modified on

2017

Year

01

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013308