UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062884 |
|---|---|
| Receipt number | R000071019 |
| Scientific Title | Feasibility of non-intubated ("tubeless") anesthesia for video-assisted thoracoscopic surgery in a single Japanese institution: a prospective observational study |
| Date of disclosure of the study information | 2026/09/12 |
| Last modified on | 2026/09/11 16:43:33 |
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Basic information
Public title
Feasibility of non-intubated ("tubeless") anesthesia for video-assisted thoracoscopic surgery in a single Japanese institution: a prospective observational study
Acronym
TUBELESS study
Scientific Title
Feasibility of non-intubated ("tubeless") anesthesia for video-assisted thoracoscopic surgery in a single Japanese institution: a prospective observational study
Scientific Title:Acronym
TUBELESS study
Region
| Japan |
Condition
Condition
Primary lung cancer, metastatic lung tumor, pneumothorax and other diseases requiring thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In thoracic surgery, conventional management with endotracheal intubation and one-lung ventilation under positive-pressure ventilation is associated with ventilation-induced lung and airway injury, as well as delayed postoperative recovery related to deep sedation and muscle relaxants. Recently, the combination of "tubeless anesthesia" -preserving spontaneous breathing without endotracheal intubation- with uniportal video-assisted thoracoscopic surgery (Uniportal VATS) has been spreading overseas, but it has not yet become widespread in Japan. The aim of this study is to develop a protocol for tubeless thoracic surgery/anesthesia suited to the Japanese setting and to verify its feasibility as a prospective observational study. Through iterative refinement of the protocol, we aim to contribute to the early recovery of a greater number of patients.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The protocol completion rate among patients scheduled for tubeless anesthesia combined with Uniportal VATS, defined as the proportion of cases in which the planned protocol was completed without conversion to endotracheal intubation or change of the planned procedure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tubeless anesthesia (an anesthetic management technique preserving spontaneous breathing without endotracheal intubation) is used to perform uniportal video-assisted thoracoscopic surgery (Uniportal VATS). Perioperative management is conducted according to a standardized protocol adapted for the Japanese setting, and the protocol completion rate and safety are evaluated.
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
Patients undergoing partial lung resection by uniportal video-assisted thoracoscopic surgery (Uniportal VATS) with an ASA-PS classification of 3 or lower. Target conditions are early-stage lung cancer or pneumothorax requiring surgical treatment.
Key exclusion criteria
Emergency surgery cases; cases in which major bleeding or prolonged surgery is anticipated; BMI > 30; cases in which a difficult airway is anticipated; patients at high risk of upper gastrointestinal reflux (post-esophagectomy, post-total gastrectomy, or cases in which fasting cannot be reliably maintained); cases in which airway management with a supraglottic device carries risk (e.g., asthma, infection); cases with suspected allergy to the drugs used; cases with elevated intracranial pressure; cases at high risk of hemodynamic instability due to cardiac disease or other conditions; cases with coagulation abnormalities; and other cases judged by the surgeon and anesthesiologist to be appropriate for exclusion.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Department of Anesthesia
Zip code
1308575
Address
4-23-15 Kotobashi Sumida Tokyo
TEL
0336336151
atsuko.hirano.12.23@gmail.com
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Miyamoto |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Ethics Committee ot Tokyo Metropolitan Bokutoh Hospital
Zip code
1308575
Address
4-23-15 Kotobashi Sumida Tokyo
TEL
0336336151
Homepage URL
bo_rinsyo_kenkyu@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Atsuko Hirano
Funding Source
Organization
Ethics Committee of Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tokyo Metropolitan Bokutoh Hospital
Address
4-23-15 Kotobashi Sumida-ku Tokyo
Tel
0336336151
bo_rinsyo_kenkyu@tmhp.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R070302
Org. issuing International ID_1
Ethics Committee of Tokyo Metropolitan Bokutoh Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 12 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071019
