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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041944
Receipt No. R000047132
Scientific Title Investigational clinical study on transpulmonary pressure in general anesthesia
Date of disclosure of the study information 2020/10/05
Last modified on 2020/11/18

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Basic information
Public title Investigational clinical study on transpulmonary pressure in general anesthesia
Acronym Investigational clinical study on transpulmonary pressure in general anesthesia
Scientific Title Investigational clinical study on transpulmonary pressure in general anesthesia
Scientific Title:Acronym Investigational clinical study on transpulmonary pressure in general anesthesia
Region
Japan

Condition
Condition Patients undergoing general anesthesia for robot-assisted laparoscopic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine other parameters linked to the esophageal pressure considered to be an approximation of pleural pressure in patients undergoing robotic-assisted laparoscopic surgery and ventilatory management.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between esophageal pressure and other respiratory parameters
Key secondary outcomes Subgroup analysis for correlation contributions

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Continuous measurement of esophageal pressure with the insertion of an esophageal pressure measuring balloon device
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1 Patients scheduled for robot-assisted laparoscopic surgery
2 Patients scheduled to use a cuffed endotracheal intubation tube
3 Patients who have been fully informed of the study, fully understood, and have given their voluntary written consent to participate in the study
Key exclusion criteria 1 Patients with known esophageal disease or known history of esophageal disease
2 Patients with a past history of upper gastrointestinal surgery
3 Patients with suspected abnormalities in the laryngeal trachea anatomy such as previous tracheostomy, airway stenosis, or tracheomalacia
4 Patients with potential complications with intralesional pressure balloon placement such as uncontrolled coagulation abnormalities, severe thrombocytopenia, nasal involvement, or esophageal varices
5 As determined by the Minister of Health, Labour and Welfare, patients evaluated as difficult to anesthetize in their pre-anesthetic state
6 Other patients who are deemed unsuitable as subjects by the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Gaku
Middle name
Last name Kawamura
Organization The University of Tokyo Hospital
Division name Anesthesiology and pain relief center
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan
TEL +81-3-3815-5411
Email gaku-kawa@umin.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Hoshino
Organization The University of Tokyo Hospital
Division name Anesthesiology and pain relief center
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan
TEL +81-3-3815-5411
Homepage URL
Email yoko-hoshino@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku,Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 05 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
2020 Year 08 Month 17 Day
Date of IRB
2020 Year 09 Month 18 Day
Anticipated trial start date
2020 Year 10 Month 08 Day
Last follow-up date
2021 Year 08 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
2020 Year 09 Month 30 Day
Last modified on
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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