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Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange

Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange - Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038635
Enrollment
200
Registered
2019-12-20
Start date
2020-01-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is mainly intended for patients undergoing thoracic surgery requiring separate lung ventilation, such as lung cancer, pneumothorax, empyema, and mediastinal tumor.

Interventions

Existing flange group New flange group

Sponsors

IZumi City General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Intended for patients who meet all of the following criteria: 1)Patients undergoing thoracic surgery requiring separate lung ventilation 2) Patients using Daiken Medical Co., Ltd.'s codec double lumen left (37Fr/35Fr) 1) 3) Patients who are over 20 years old when obtaining consent (regardless of gender) 4) Patients who have received sufficient explanation for participation in this study, and who have obtained written consent from the patient or his / her proxy 1) Daiken Medical Equipment Co., Ltd. codec double lumen is sold only for the left side. The new flange is not yet compatible with sizes 32Fr and 39Fr.

Exclusion criteria

Exclusion criteria: Patients who violate any of the following will not be included in this study: 1) Patients judged to be inappropriate by the study director [Rationale for setting] 1) In order to leave room for the research director to decide whether or not to participate in this study, taking into account the general factors other than those mentioned above, taking into account the safety of the subject.

Design outcomes

Primary

MeasureTime frame
1) New incidence: In each group, the number of new patients is divided by the number of target patients and calculated as a percentage. Before and after tracheal intubation, observe the teeth and lips and exclude any damage caused by intubation. 2) Site and extent of damage: The parts are classified into the lips, mouth corners, upper, lower, left and right around the mouth, the cheeks are above and below the nostrils, and the oral cavity is classified into the upper and lower parts of the alveoli and the tongue The hard palate is excluded because it does not touch the structure. 3) Degree of damage: classified into redness, epidermal detachment, laceration, ulcer and blister Sensory abnormalities include numbness, pain, and numbness The range is described in mm (vertical * horizontal), and the depth is not evaluated because a measurable laceration is not expected. Allows multiple selection of applicable items

Secondary

MeasureTime frame
1)Degree of bronchial tube displacement: When confirming the position of the tube with a bronchoscope, measure the distance (mm)from the tracheal branch to the tube opening for right lung ventilation to measure the extraction distance of the bronchoscope. 2)Safety assessment,Adverse events Frequency of tube trouble: The case where the bronchial tube is displaced and the lung on the operation side swells or is inserted deeper and the position of the bronchial tube needs to be corrected during the operation.

Countries

Japan

Contacts

Public ContactRyuji Kajikawa

IZumi City General Hospital Department manager of Anesthesiology

ryuji.kajikawa@tokushukai.jp0725411331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026