UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053995 |
|---|---|
| Receipt number | R000061180 |
| Scientific Title | Effect of intraoperative low-pressure ventilation intervention on intraoperative blood loss in ovarian tumour surgery: a randomised controlled trial. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/28 16:29:39 |
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Basic information
Public title
Effect of intraoperative low-pressure ventilation intervention on intraoperative blood loss in ovarian tumour surgery: a randomised controlled trial.
Acronym
Randomised controlled trial of low-pressure ventilation intervention for blood loss in ovarian tumour surgery.
Scientific Title
Effect of intraoperative low-pressure ventilation intervention on intraoperative blood loss in ovarian tumour surgery: a randomised controlled trial.
Scientific Title:Acronym
Effect of intraoperative low-pressure ventilation intervention on intraoperative blood loss in ovarian tumour surgery
Region
| Japan |
Condition
Condition
Ovary cancer
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Ovarian malignancy surgery is a highly invasive procedure with a high transfusion rate. On the other hand, as transfusion has been reported to worsen the prognosis of cancer, systemic management to reduce blood loss needs to be considered. The aim of this study is to investigate whether intraoperative ventilatory management in ovarian cancer surgery, mainly by intervening with end-expiratory positive pressure (PEEP), can reduce blood loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraoperative blood loss
Key secondary outcomes
Estimated blood loss
Perioperative transfusion volume and transfusion rate
Estimated and actual ascites volume
Postoperative chest x-ray for atelectasis
Estimated blood loss at 1 week post-operatively
Respiratory events at 1 week postoperatively
Postoperative complications Clavien-Dindo classification at 1 week and 30 days
Length of hospital stay
In-hospital mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Low-pressure ventilation and low venous pressure interventions are continued from the start of surgery until the end of surgery.
The intervention group is managed with zero PEEP and TV 6 ml/kg, and preferentially with norepinephrine and no artificial colloidal fluid for pressure boosting purposes.
Interventions/Control_2
In the control group, PEEP of 5 cm H2O or more is added, TV 8 ml/kg is managed according to usual practice, and there are no restrictions on infusion management or use of vasopressor drugs.
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Patients undergoing ovarian cancer surgery at Chiba University Hospital.
Key exclusion criteria
1.Minors
2.Emergency surgery
3.Patients for whom an experimental laparotomy will be performed in this surgery
4.Obese with a BMI of 30 or more
5.Patients diagnosed with chronic obstructive pulmonary disease
6. Patients under treatment for asthma (included in eligible patients if only pre-existing)
7.Patients with complications of heart failure
8.Patients with severe sleep apnoea syndrome
9.Smokers (if they have not stopped smoking for at least one month)
10.Anaemia Hb <9g/dl
11.Coagulation abnormalities APTT > 42 seconds, PT > 17 seconds
12.Platelets <100,000
13.Patients with preoperative physical status 4 or 5 of the American Society of Anaesthesiologists
14.Patients with a history of laparotomy (excluding exploratory laparotomy due to ovarian cancer)
15.Patients with ChildB or C cirrhosis
16.Patients with missing data
17.Patients deemed unsuitable as subjects by the principal (sub)investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kyongsuk |
| Middle name | |
| Last name | Son |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
2608677
Address
1-8-1 Inohana Chuuou-ku, Chiba-shi, 260-8677 JAPAN
TEL
0432227171
adaya5599@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kyongsuk |
| Middle name | |
| Last name | Son |
Organization
Chiba-University Hospital
Division name
Department of Anesthesiology
Zip code
2608677
Address
1-8-1 Inohana Chuuou-ku, Chiba-shi, 260-8677 JAPAN
TEL
0432227171
Homepage URL
adya5599@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Kyongsuk
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Ethics Review Board
Address
1-8-1 Inohana Chuuou-ku, Chiba-shi, 260-8677 JAPAN
Tel
0432227171
prc-jim@chiba-u.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
| 2024 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061180
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