UMIN-CTR Clinical Trial

Basic information
Public title	Variation of Respiratory Compliance during artificial pneumothorax under two-lung Ventilation in Video-assisted Thoracoscopic Esophagectomy for esophageal cancer in the prone position
Acronym	Variation of Respiratory Compliance during artificial pneumothorax under two-lung Ventilation in Video-assisted Thoracoscopic Esophagectomy for esophageal cancer in the prone position
Scientific Title	Variation of Respiratory Compliance during artificial pneumothorax under two-lung Ventilation in Video-assisted Thoracoscopic Esophagectomy for esophageal cancer in the prone position
Scientific Title:Acronym	Variation of Respiratory Compliance during artificial pneumothorax under two-lung Ventilation in Video-assisted Thoracoscopic Esophagectomy for esophageal cancer in the prone position
Region	Japan

Condition
Condition	patients who underwent VATS-E performed by the same surgeon
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	By measuring changes in respiratory mechanics through the use of new ventilators that can measure pulmonary compliance and esophageal pressure, rather than the ventilators attached to the anesthesia machine used during surgery, and by elucidating the respiratory mechanics through new respiratory physiological indicators such as transpulmonary pressure, the mechanisms of postoperative pulmonary complications will be elucidated. Furthermore, the aim is to examine the appropriate pulmonary protective respiratory setting during esophageal cancer surgery. Translated with www.DeepL.com/Translator (free version)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of change in thoracic-lung compliance, airway resistance and transpulmonary pressure during supine, prone and pneumothorax
Key secondary outcomes	Percentage change in pH, partial pressure of arterial blood oxygen, partial pressure of arterial blood carbon dioxide and P/F ratio during supine, supine and pneumothorax

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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients diagnosed with esophageal cancer and indicated for specular esophagectomy 2) Patients under general anesthesia who undergo a specular esophagectomy 3) Age: 20 years and older 4) Gender: any gender 5) By inpatient/outpatient category: inpatients 6) Patients who have given their voluntary consent to participate in the study in writing with a full explanation 7) American Society of Anesthesiologists preoperative status classification of III or less. Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria	1) Patients who are difficult to manipulate thoracoscopically (scoliosis, contracture, severe adhesions) 2) Patients unable to lie supine. 3) Patients with communication difficulties due to dementia, mental illness, etc. 4) Patients with an American Society of Anesthesiologists preoperative status classification of IV or higher 5) Patients with serious concomitant breathing problems 6) Other patients whose participation in the study is judged to be problematic by the principal investigator or research co-investigator. Translated with www.DeepL.com/Translator (free version)
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Tanigawa
Organization	Saga University Hospital
Division name	Anesthesiology and Critical Care Medicins
Zip code	849-8501
Address	5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL	0952343370
Email	e6580@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Tanigawa
Organization	Saga University Hospital
Division name	Anesthesiology and Critical Care Medicins
Zip code	849-8501
Address	5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL	0952343370
Homepage URL
Email	e6580@cc.saga-u.ac.jp

Sponsor
Institute	Saga University Hospital
Institute
Department

Funding Source
Organization	Saga University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saga University Hospital
Address	5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
Tel	0952343370
Email	e6580@cc.saga-u.ac.jp

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	佐賀大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 19 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	Preinitiation
Date of protocol fixation	2020 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 17 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2020 Year 10 Month 19 Day
Last modified on	2020 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048134