UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036376 |
|---|---|
| Receipt number | R000041444 |
| Scientific Title | Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure for titrating optimal PEEP. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/04/03 17:56:41 |
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Basic information
Public title
Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure for titrating optimal PEEP.
Acronym
Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure.
Scientific Title
Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure for titrating optimal PEEP.
Scientific Title:Acronym
PEEP titration using transpulmonary pressure in robot assisted prostate surgery.
Region
| Japan |
Condition
Condition
Participants in this study will be the patients who fulfill the following criteria.
1.The patients who have prostatic cancer and will have elective robot-assisted surgery.
2.The age does not matter.
3.The patients with the risk 1 or 2 of the ASA(American Society of Anesthesiologist) .
4.The BMI of the patients is less than 35
5.The patients with NYHA1 and Hugh-Jones1
6.The patients who can sign a consent form to participate this study
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Robot assisted surgery (Da Vinci Surgery) has been applied to various kinds of operations. It is necessary to pay special attention to the respiratory management in robot assisted laparoscopic prostate (RALP) surgery, because of pneumoperitoneum and Trendelenburg position.
It has not necessarily been discussed how inspiratory and end expiratory pressure should be controlled during RALP surgery. Evaluating the stress on the the alveolar wall is important to prevent varotrauma while keeping the alvelus open,There are several methods to determine PEEP levels, among them, PEEP based on transpulmonary pressure has been attracting attention in ARDS. When the airway pressure at the end expiration is below the intrathoracic pressure, i.e. transpulmonary pressure at end expiration is less than 0, then the alveoli may collapse (pulmonary pressure equal airway pressure intrathoracic pressure). Intrathoracic pressure can be substituted with esophageal pressure measured by using an esophageal balloon catheter. It is speculated that intrathoracic pressure is elevated during RALP surgery, and lower PEEP will induce negative transpulmonary pressure and promotes alveolar atelectasis at the end of expiration.
The purpose of the study is to observe the changes in intrapleural pressure by increasing PEEP and to determine the optimal PEEP where transpulmonary pressure exceeds 0. We also observe the cardiac output and the cerebral oxygenation changes concomitantly with PEEP elevation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.transpulmonary pressure
2.airway pressure(peak airway pressure,inspiratory plateau pressure,mean airway pressure,PEEP)
3.esophageal pressure(peak,mean,end-expiratory)
4.P/F ratio
Key secondary outcomes
1.hart rate,arterial pressure
2.SpO2, ORI oxygen reserve index
3.arterial blood gas
4.lung thorax compliance
5.cerebral oxygen saturation:rSO2
6.Vigileo monitor Cardiac Output, Stroke Volume Stroke Volume Variation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
10cases
Duration of this study 2019.3.4-2019.12.31
The ventilation settings is normal until the operation starts.When head downed,pneumoperitoneum started,we add the PEEP from 0cmH2O to 15cmH2O by 5cmH20 up in every 30 minutes.Then the end expiratory airway pressure and esophageal pressure are monitored.
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
| Not applicable |
Gender
Male
Key inclusion criteria
Participants in this study will be the patients who fulfill the following criteria.
1.The patients who have prostatic cancer and will have elective robot-assisted surgery.
2.The age does not matter.
3.The patients with the risk 1 or 2 of the ASA(American Society of Anesthesiologist) .
4.The BMI of the patients is less than 35
5.The patients with NYHA1 and Hugh-Jones1
6.The patients who can sign a consent form to participate this study
Key exclusion criteria
1.The past history of a disorder of the central nervous system
2.The past of the thoracic operation.
3.The past of the myocardial infarction or heart failure
4.Problem with insertion in the esophagus.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ami |
| Middle name | |
| Last name | Kodaira |
Organization
Tokyo Medical University Hospital
Division name
department of anesthesia
Zip code
160-0023
Address
6-7-1 Nishishinjyuku,shinjyukuku,Tokyo
TEL
03-3342-6111
kodaami68@gmail.com
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Kodaira |
Organization
Tokyo Medical University Hospital
Division name
department of anesthesiology
Zip code
160-0023
Address
6-7-1 Nishishinjyuku,shinjyukuku,Tokyo
TEL
03-3342-6111
Homepage URL
kodaami68@gmail.com
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical 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
Center for Research Administration and Innovation, Tokyo Medical University.
Address
6-7-1 Nishishinjyuku,shinjyukuku,Tokyo
Tel
03-3342-6111
Adm_IRB@tokyo-med.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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-openbin/ ctr/ctr.cgi?function=brows&action=brows&recptno=R000041444&ty
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-openbin/ ctr/ctr.cgi?function=brows&action=brows&recptno=R000041444&ty
Number of participants that the trial has enrolled
14
Results
The median PEEP level associated with PtpEEP0 was 15 cmH2O. Respiratory system compliance values were higher at PtpEEP0 than those at PEEP5 (P = 0.02). Driving pressure was lower at PtpEEP0 than at PEEP5 (P=0.0036). The cardiac index remained unchanged, and the values of rSO2 were higher at PtpEEP0 than at PEEP0 (right; P=0.0019, left; P=0.036).
Results date posted
| 2022 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled male patients with the American Society of Anesthesiologists (ASA) Physical Status Classification score of 1 or 2 points, scheduled for RARP using a robotic operating system.
Participant flow
Written informed consent was obtained from 16 patients enrolled in the study. Two patients were excluded due to esophageal balloon catheter failure; a total of 14 patients were included.
Adverse events
No
Outcome measures
PEEP levels where endexpiratory Ptp levels of more than0 cmH2O were achieved (PtpEEP0). Airway pressure, esophageal
pressure, cardiac index, and blood gas and rSO2 values
after 30 minutes at each PEEP step.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2019 | 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
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041444
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