UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050253 |
|---|---|
| Receipt number | R000057230 |
| Scientific Title | Prospective observational study on ventilation parameters during general anesthesia |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2025/02/07 12:38:24 |
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Basic information
Public title
Prospective observational study on ventilation parameters during general anesthesia
Acronym
Prospective observational study on ventilation parameters during general anesthesia
Scientific Title
Prospective observational study on ventilation parameters during general anesthesia
Scientific Title:Acronym
Prospective observational study on ventilation parameters during general anesthesia
Region
| Japan |
Condition
Condition
non
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between mechanical power, age, and complications during mechanical ventilation in children.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pediatric mechanical power during mechanical ventilation
Key secondary outcomes
Relationship between mechanical power, age, and complications in children during mechanical ventilation
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Pediatric patients undergoing general anesthesia for surgery performed at the facility
(2) Pediatric patients undergoing airway management with a cuffed tracheal tube
(3) Age 18 years old or younger (at the time of enrollment) (to investigate the standard value of mechanical power in children of a wide range of ages)
(4) Gender: Both
Key exclusion criteria
(1) Patients with difficult tracheal intubation
(2) Patients whose surgical technique affects mechanical ventilation
(3) Patients whose height and weight development is delayed (advanced) by 2 SD or more
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7321
Homepage URL
takahashi.kazuhiro@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Department of Anesthesiology and Perioperative Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
Tohoku University School of Medicine Research Cooperation Section Faculty of Medicine Graduate School of Medicin
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.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
| 2023 | Year | 02 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Method
1. General anesthesia is induced for the target patient and tracheal intubation is performed.
2. The method of anesthesia is left to the judgment of the attending anesthesiologist and is not specified.
3. Information on the tracheal tube used (type, size, length), anesthesia machine, and ventilation volume during the stabilization period of general anesthesia instrument information (ventilator settings, tidal volume, airway pressure/flow rate, resistance/compliance, anesthetic gas set), biometric information (heart rate, blood pressure, oxygen saturation, end-tidal carbon dioxide partial pressure, etc.).
4. Calculate the mechanical power from the recorded information and examine the relationship with age, height, weight, and postoperative complications.
be.
Management information
Registered date
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057230
