UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042544 |
|---|---|
| Receipt number | R000048433 |
| Scientific Title | A prospective observational study: the effects of anesthetic gas composition and tracheal tube length on airway resistance during general anesthesia |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2023/02/07 11:46:58 |
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Basic information
Public title
A prospective observational study: the effects of inhalational anesthetic and tracheal tube on airway resistance during general anesthesia
Acronym
A prospective observational study: the effects of inhalational anesthetic and tracheal tube on airway resistance during general anesthesia
Scientific Title
A prospective observational study: the effects of anesthetic gas composition and tracheal tube length on airway resistance during general anesthesia
Scientific Title:Acronym
A prospective observational study: the effects of anesthetic gas composition and tracheal tube length on airway resistance 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 effects of changes in anesthetic gas composition and tracheal tube length during general anesthesia on tidal volume, airway pressure, flow velocity, and resistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in tidal volume due to changes in anesthetic gas composition or tracheal tube length
Key secondary outcomes
ventilatory information (ventilator settings, airway pressure, flow velocity, resistance, anesthetic gas composition, tracheal tube length), biometric information (heart rate, blood pressure, oxygen saturation, end-tidal carbon dioxide tension)
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
| 1 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients undergoing general anesthesia
(2) Patients intubated with a cuffed tracheal tube
(3) Patients managed with pressure-controlled ventilation
Key exclusion criteria
(1) Patients with respiratory diseases
(2) Patients with difficulty in tracheal intubation
(3) Patients whose surgical procedure affects ventilatory parameters
(4) Patients with risk factors for malignant hyperthermia due to inhalation anesthetic
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | masanori |
| Middle name | |
| Last name | yamauchi |
Organization
Tohoku University School of Medicine
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 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 School of Medicine
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 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 School of Medicine
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 Medicine
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
| 2020 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
doi: 10.1620/tjem.2022.J003. Epub 2022 Mar 17.
Number of participants that the trial has enrolled
30
Results
In the clinical study, the change in tidal volume per body weight, accompanied by gas composition change (2% sevoflurane in oxygen and with 0-30-60% of N2O), was recorded in 30 pediatric patients. The median tidal volume per body weight decreased by 10% when the respiratory gas density increased from 1.41 kg/m3 to 1.70 kg/m3, indicating a significant between-group difference (P < 0.0001).
Results date posted
| 2022 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 17 | Day |
Baseline Characteristics
This prospective observational study was conducted at Tohoku University Hospital, and patients aged 1-12 years undergoing elective surgery under general anesthesia, with PCV via cuffed endotracheal tube, at the hospital were considered for participation
in this study. Exclusion criteria of this study were the presence of respiratory disease, difficult airway, and a risk of malignant hyperthermia.
Participant flow
Written documentation of informed consent was obtained　from the parents of all study participants.
Adverse events
non
Outcome measures
In the clinical study, the change in tidal volume per body weight, accompanied by gas composition change (2% sevoflurane in oxygen and with 0-30-60% of N2O), was recorded.
Plan to share IPD
non
IPD sharing Plan description
non
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study.
In this study, we record ventilatory parameters before and after intervention which cause changes in airway resistance during general anesthesia. The intervention includes anesthetic gas composition change and tube shortening.
The change in gas composition and the endotracheal tube shortening are considered to be independent explanatory variables of each other and should be analyzed as independent events. Data acquisition of tidal volume is performed immediately before and after either event and even if gas composition change and endotracheal tube shortening are performed on the same patient, they are not considered to affect each other's data analysis.
Data acquisition for this study has already been completed.
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | 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=R000048433
