UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041944 |
|---|---|
| Receipt number | 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 | 2023/10/04 10:44:28 |
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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
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
yoko-hoshino@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000047132
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000047132
Number of participants that the trial has enrolled
20
Results
Data were available for a total of 18 patients.
The correlation coefficient between intraesophageal pressure and cuff pressure during inspiration was 0.58, and the BA analysis showed a fixed error. The correlating coefficient between intraesophageal pressure and cuff pressure during expiration was 0.23, and the BA analysis showed a systematic error.
Results date posted
| 2023 | Year | 10 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Additional verification of the results was needed.
Date of the first journal publication of results
Baseline Characteristics
Ave. (25tile-75tile)
Age 66.8 (61.3-72.3)
Hight, cm 166.9(164-169.5)
Body Weight, kg 63.5 (58.5-69)
BMI, kg/m2 22.8 (20.9-25.3)
Vital capacity, L 4.0(3.6-4.2)
Forced Vital Capacity, 72.5 (66.7-78.6)
Ope time, min 299 (223-339)
Depth of intubation tube, cm 23.7(23-24)
Depth of esophageal balloon catheter, cm 71.4(70-72.5)
Participant flow
As planned
Adverse events
no
Outcome measures
Data were available for a total of 18 patients.
The correlation coefficient between intraesophageal pressure and cuff pressure during inspiration was 0.58, and the BA analysis showed a fixed error. The correlating coefficient between intraesophageal pressure and cuff pressure during expiration was 0.23, and the BA analysis showed a systematic error.The correlation coefficient between cuff pressure and intra-airway pressure during inspiration was 0.68, and that between intra-esophageal pressure and intra-airway pressure during inspiration was 0.87.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047132
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
