UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030987 |
|---|---|
| Receipt number | R000032340 |
| Scientific Title | The effect of intra-operative mechanical ventilation on postoperative outcomes; Historical control study |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2023/01/30 10:51:14 |
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Basic information
Public title
The effect of intra-operative mechanical ventilation on postoperative outcomes; Historical control study
Acronym
The effect of intra-operative mechanical ventilation on postoperative outcomes
Scientific Title
The effect of intra-operative mechanical ventilation on postoperative outcomes; Historical control study
Scientific Title:Acronym
The effect of intra-operative mechanical ventilation on postoperative outcomes
Region
| Japan |
Condition
Condition
Gynecological illness
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Complications after general anesthesia include postoperative nausea and vomiting (PONV).In some reports, the risk factors for PONV are female, nonsmokers, a history of PONV and a history of motion sickness, use of narcotics, use of volatile anesthetics, etc.One study has shown that PONV can be reduced by keeping high end tidal carbon dioxide concentration (EtCO2) during intraoperative operation.However, there is no study that examined the relationship between intra-operative EtCO 2 and PONV in gynecologic surgery, which is a high risk group of PONV.In our hospital January 2014 - June 2016, the incidence of PONV of gynecologic surgery was 54.4%.The minimum intraoperative EtCO 2 was significantly lower in the PONV group and the cutoff value for PONV was 32 mm Hg.The purpose of this study is to investigate whether PONV will occur in intervention group keeping the intrao-perative EtCO2 value at 40 - 45 mmHg compared to group that did not set EtCO2 high (EtCO2 <40 mm Hg) in January 2014 - March 2018 by using a propenity score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PONV within 24 hours after surgery
Key secondary outcomes
Use of PONV remedy within 24 hours after surgery
Atelectasis score in X-ray immediately after surgery
Postoperative pneumonia
Postoperative complication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Set the end tidal carbon dioxide(EtCO2) in the ventilator to 40-45 mmHg during the surgery
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Patients aged 20 to over 60 when acquiring consent
(2) Patients gained consent for participation in this study at their own will
Key exclusion criteria
Patients applicable to one or more of the following are excluded.
(1) Patients with ASA risk classification of 3 or more
(2) Patients with BMI 30 kg / m 2
(3) Other patients judged inappropriate by the person in charge of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
kobe university hospital
Division name
Anesthesiology
Zip code
6500017
Address
7-5-2 kusunoki-cho tyuo-ku kobe city
TEL
078-382-6172
anesth@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
kobe university hospital
Division name
Anesthesiology
Zip code
6500017
Address
7-5-2 kusunoki-cho tyuo-ku kobe city
TEL
078-382-6172
Homepage URL
anesth@med.kobe-u.ac.jp
Sponsor or person
Institute
kobe university hospital
Institute
Department
Personal name
Funding Source
Organization
kobe university hospital
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
IRBcomittee Kobe university hospital
Address
7-5-2 Kusunokityo Kobe City Hyogo
Tel
078-382-5111
moriori@tg8.so-net.ne.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
| 2018 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032340
