UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056943 |
|---|---|
| Receipt number | R000064449 |
| Scientific Title | Epidemiological study of the impact on clinical outcomes with the introduction of ventilation algorithm: An interrupted time series analysis. |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2025/02/05 14:12:13 |
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Basic information
Public title
Epidemiological study of the impact on clinical outcomes with the introduction of ventilation algorithm: An interrupted time series analysis.
Acronym
Epidemiological study of the impact on clinical outcomes with the introduction of ventilation algorithm
Scientific Title
Epidemiological study of the impact on clinical outcomes with the introduction of ventilation algorithm: An interrupted time series analysis.
Scientific Title:Acronym
Epidemiological study of the impact on clinical outcomes with the introduction of ventilation algorithm
Region
| Japan |
Condition
Condition
Respiratory failure in need of mechanical ventilation management
Classification by specialty
| Cardiology | Pneumology | Nephrology |
| Neurology | Clinical immunology | Infectious disease |
| Surgery in general | Vascular surgery | Chest surgery |
| Cardiovascular surgery | Operative medicine | Emergency medicine |
| Intensive care medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ventilator management in the intensive care unit (ICU) is an important treatment for severe respiratory failure, but physicians vary in their use of ventilators and there is a shortage of healthcare professionals who can use ventilators correctly (PMID: 36566030). Therefore, there is a need to develop and implement a standardized ventilation management algorithm. The Standard Training and Operating Procedure for Mechanical Ventilation (STOP-MV) was developed by the Mayo Clinic as a standardized algorithm for mechanical ventilation. This algorithm details the assessment of ventilated patients in the ICU according to their vital signs and ventilator settings, and is designed to enable safe ventilatory management even for novice students. The aim of this study was to implement this ventilation algorithm in a single institution to assess the following.
1) Improved prognosis of ventilated patients.
2) Changes in ventilation-related knowledge of inexperienced physicians
3) Identification of problems and improvements in the implementation of the algorithm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
duration of ventilator days
Key secondary outcomes
Re-intubated or not, date of ICU discharge, alive or not at ICU discharge, date of hospital discharge, alive or not at discharge, date of death, ventilator-free days, 28-day death.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Continue with usual patient care without implementing the PIT STOP MVP ventilator assessment algorithm. Each day, for each patient, the presence or absence of ventilation, ventilator setting mode, predicted body weight, minute ventilation, maximum airway pressure, PEEP, driving pressure, pressure support pressure, presence or absence of algorithm use, and the number of times the algorithm is used are recorded.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients expected to require ventilation for more than 24 hours
Key exclusion criteria
Patients expected to be weaned from ventilator within 24 hours
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Konno |
Organization
Tohoku University Hospital
Division name
Tohoku University School of Medicine Department of Anesthesiology and Perioperative Medicine
Zip code
090-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177321
daisuke.konno.e4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Konno |
Organization
Tohoku University Hospital
Division name
Tohoku University School of Medicine Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177321
Homepage URL
anessecretary@tohokuanes.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Tohoku University School of Medicine Department of Anesthesiology and Perioperative Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
0227177321
daisuke.konno.e4@tohoku.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
| 2025 | Year | 02 | Month | 06 | 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 | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064449
