UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042174
Receipt number R000048134
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
Date of disclosure of the study information 2020/10/19
Last modified on 2020/10/19 19:29:23

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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 or person

Institute

Saga University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name