UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054781 |
|---|---|
| Receipt number | R000062605 |
| Scientific Title | Evaluation of the hemodynamic management suggestion function of the Acumen IQ sensor (Edwards Lifesciences): a comparison of resident and specialist responses. |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/06/26 14:40:38 |
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Basic information
Public title
Evaluation of the hemodynamic management suggestion function of the Acumen IQ sensor (Edwards Lifesciences): a comparison of resident and specialist responses.
Acronym
Evaluation of the hemodynamic management suggestion function of the Acumen IQ sensor (Edwards Lifesciences): a comparison of resident and specialist responses.
Scientific Title
Evaluation of the hemodynamic management suggestion function of the Acumen IQ sensor (Edwards Lifesciences): a comparison of resident and specialist responses.
Scientific Title:Acronym
Evaluation of the hemodynamic management suggestion function of the Acumen IQ sensor (Edwards Lifesciences): a comparison of resident and specialist responses.
Region
| Japan |
Condition
Condition
Patients aged 18 years or older undergoing laparoscopic colectomy.
Patients who have received thorough explanations and consented to participate in the study.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the appropriateness of responses to the suggestions provided by Edwards' Acumen AI and HPI in anesthetic management and to compare the responses between residents (with less than 2 years of experience) and specialists (with over 6 years of experience). Specifically, this study aims to elucidate:
The appropriateness of the suggestions and HPI.
The speed of responses.
Blood pressure recovery time.
The frequency and causes of errors.
The incidence of postoperative complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Physiological Stability
Intraoperative blood pressure variability (mean arterial pressure stability)
Intraoperative heart rate variability
Anesthetic Usage
Total amount of anesthetics used (e.g., propofol, remifentanil)
Surgery Duration
Total surgery time
Time from anesthesia induction to awakening
Intraoperative and Postoperative Safety
Intraoperative acute adverse events (e.g., allergic reactions, acute hypotension)
Postoperative complications (e.g., infections, bleeding, need for reoperation)
Patient Postoperative Recovery
ICU stay duration
Postoperative hospital stay duration
Postoperative recovery score (e.g., Pain Score, Recovery Room Stay Duration)
Staff Satisfaction
Satisfaction of anesthesiologists and surgical team with the suggestions and HPI
Cost-Effectiveness
Comparison of costs related to anesthetic management and postoperative care
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo laparoscopic colectomy
Patients aged 18 years or older
Patients who have received thorough explanations and consented to participate in the study
Key exclusion criteria
Pregnant or breastfeeding patients
Patients with severe cardiovascular diseases
Patients undergoing emergency surgery
Patients who are unable to comply with the study protocol (e.g., patients with severe cognitive impairment)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
317-0077
Address
2-1-1 Jonancho Hitachi Ibaraki
TEL
0294-23-1111
musashi.yahagi.tu@hitachi.com
Public contact
Name of contact person
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
317-0077
Address
2-1-1 Jonancho Hitachi Ibaraki
TEL
0294-23-1111
Homepage URL
musashi.yahagi.tu@hitachi.com
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
N.A.
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
Hitachi General hospital
Address
2-1-1 Jonancho Hitachi Ibaraki
Tel
0294-23-1111
musashi.yahagi.tu@hitachi.com
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 | 06 | Month | 26 | 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
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062605
