UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054061 |
|---|---|
| Receipt number | R000061722 |
| Scientific Title | The effect of low tidal volume to dynamic arterial elastance in the laparoscopic surgery |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2025/03/02 16:07:36 |
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Basic information
Public title
The effect of low tidal volume to dynamic arterial elastance in the laparoscopic surgery
Acronym
The effect of low tidal volume to dynamic arterial elastance in the laparoscopic surgery
Scientific Title
The effect of low tidal volume to dynamic arterial elastance in the laparoscopic surgery
Scientific Title:Acronym
The effect of low tidal volume to dynamic arterial elastance in the laparoscopic surgery
Region
| Japan |
Condition
Condition
Laparoscopic surgery patient with inserted arterial line during general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether the accuracy of dynamic arterial elastance (Eadyn) in predicting blood pressure responsiveness after fluid administration is affected by low tidal ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In laparoscopic surgery patients undergoing general anesthesia with an inserted arterial line, when patients had mean arterial pressure less than 65mmHg and SVV >10%, the Ea dyn at each point will be measured by varying the volume of ventilation from 8 ml/ideal body weight to 6 ml/ideal body weight. The Ea dyn at each point will be measured. Afterwards, 250 ml of Ringer's solution will be administered rapidly, and patients with a 10% or greater increase in mean arterial pressure will be defined as responders.
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
| Other |
Interventions/Control_1
Bolus infusion of 250ml of Ringers solution
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled laparoscopic surgery patients with scheduled arterial catheter insertion and cardiac output monitoring..
Key exclusion criteria
Patients with cardiac ejection fraction less than 40% / patients with atrial fibrillation / patients with severe COPD / patients with right heart failure / highly obese patients (BMI>35) / highly classically thin patients (BMI<15) / supine surgery / side lying surgery / surgery requiring isolated lung ventilation / patients not using laparoscopy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | YUSUKE |
| Middle name | |
| Last name | IIZUKA |
Organization
Jichi medical university, saitama medical center
Division name
Department of anesthesiology and critical care medicine
Zip code
3308503
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
TEL
+81486472111
zukarinn@gmail.com
Public contact
Name of contact person
| 1st name | YUSUKE |
| Middle name | |
| Last name | IIZUKA |
Organization
Jichi medical university, saitama medical center
Division name
Department of anesthesiology and critical care medicine
Zip code
330-8503
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
TEL
+81486472111
Homepage URL
zukarinn@gmail.com
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Funding Source
Organization
None
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
Department of Anesthesiology and Critical care medicine, Jichi medical university, Saitama medical center
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
Tel
+81486472111
s-suishin@jichi.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
| 2024 | Year | 04 | Month | 04 | 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
60
Results
Forty six patients were analyzed. Eleven were classified as MAP non responders, and 35 as MAP responders. SVV and PPV changed significantly with change in tidal volume, whereas Eadyn remained similar value. Neither value of Eadyn could not predict MAP responsiveness. (8ml/PBW setting ROC:0.514, 95% CI 0.314 0.715, 6ml/PBW setting ROC:0.508, 95% CI 0.319 0.697)
Results date posted
| 2025 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061722
