UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014004 |
|---|---|
| Receipt number | R000016295 |
| Scientific Title | The examination of the efficiency of ventilation setting during anesthesia |
| Date of disclosure of the study information | 2014/05/20 |
| Last modified on | 2019/03/20 16:16:55 |
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Basic information
Public title
The examination of the efficiency of ventilation setting during anesthesia
Acronym
Efficiency of ventilation setting
Scientific Title
The examination of the efficiency of ventilation setting during anesthesia
Scientific Title:Acronym
Efficiency of ventilation setting
Region
| Japan |
Condition
Condition
From 18 to 85 years old patients with elective operation of a one lung ventilation operation, laparoscopic surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficiency of a ventilation setting using Volumetric-Capnography
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Airway and alveolar deadspace
carbon dioxide elimination
Key secondary outcomes
PaO2, PaCO2
blood pressure, heart rate
cardiac index, stroke volume variation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Volume control ventilation
TV = 6-8 ml/kg
I:E = 1:2
RR = 10 /min
PEEP = 5-10 mmHg
Interventions/Control_2
Pressure control ventilation
TV = 6-8 ml/kg (same as control)
I:E = 1:2
RR = 10 /min
PEEP = 5-10 mmHg
Interventions/Control_3
Pressure control ventilation
TV = 6-8 ml/kg (same as control)
I:E = 1:1
RR = 10 /min
PEEP = 4 mmHg
Interventions/Control_4
Pressure control ventilation
TV = 6-8 ml/kg (same as control)
maximum I:E (minimum expiration time)
RR = 10 /min
PEEP off
Interventions/Control_5
Pressure control ventilation
Pressure < 25 mmHg
maximum I:E (minimum expiration time)
RR = 10 /min
PEEP off
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA 1-2, not excluded morbid obesity, undergoing thoracotomy requiring one lung ventilation, or laparoscopic surgery.
Key exclusion criteria
ASA 3 or greater or patients
undergoing emergency surgery were not studied
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Hirabayashi |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
213-8507
Address
3-8-3 Mizonokuchi Takatsu-Ku Kawasaki Kanagawa
TEL
044-844-3333
flatwood@aa.cyberhome.ne.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Hirabayashi |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
213-8507
Address
3-8-3 Mizonokuchi Takatsu-Ku Kawasaki Kanagawa
TEL
044-844-3333
Homepage URL
flatwood@aa.cyberhome.ne.jp
Sponsor or person
Institute
Mizonokuchi Hospital, Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
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
Mizonokuchi Hospital, Teikyo University School of Medicine
Address
74 Mizonokuchi Takatsu-Ku Kawasaki Kanagawa
Tel
044-844-3333
chiken@med.teikyo-u.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
帝京大学医学部附属溝口病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29303905
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29303905
Number of participants that the trial has enrolled
20
Results
The VDphys/expired tidal volume (VTE) ratio in PC-IRV (29%) was significantly reduced compared with that in VCV (43%) and in PCV (36%). The VDshunt/VTE in PC-IRV was significantly smaller than that in VCV and PCV. VDaw/VTE in PC-IRV was also significantly smaller than that in VCV but not that in PCV. There was no significant change in VDalv/VTE.
Results date posted
| 2019 | Year | 03 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
sex male/female 20/0
age (years) 71
height (cm) 165
weight (kg) 64
BMI (kg/cm2) 23
pulmonary function test(n)
normal 18, obstract 2
ASA PS 1; 11, 2; 9
Participant flow
Patients were ventilated with three different modes for 30 min sequentially in random order: volume control ventilation (VCV; I/E ratio 0.5), pressure control ventilation (PCV; I/E ratio 0.5), and PC-IRV. Inverse I/E ratio was adjusted individually by observing the expiratory flow-time wave to prevent the risk of dynamic pulmonary hyperinflation.
Adverse events
none
Outcome measures
We analyzed VDresp, VDaw and VDalv using novel volumetric capnography and with an arterial blood gas sample, PaCO2, VDphys and VDshunt were calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016295
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