UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053970 |
|---|---|
| Receipt number | R000061603 |
| Scientific Title | THE EFFECTS OF PROTECTIVE MECHANICAL VENTILATION TECHNIQUES ON RESPIRATORY DYNAMICS, HEMODYNAMICS AND BLOOD GAS PARAMETERS FOR NEUROSURGERY CASES IN PRONE POSITION |
| Date of disclosure of the study information | 2024/03/26 |
| Last modified on | 2024/03/26 06:43:42 |
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Basic information
Public title
THE EFFECTS OF PROTECTIVE MECHANICAL VENTILATION TECHNIQUES ON RESPIRATORY DYNAMICS, HEMODYNAMICS AND BLOOD GAS PARAMETERS FOR NEUROSURGERY CASES IN PRONE POSITION
Acronym
PEEP:Positive End-Expiratory Pressure
ASA:American Society of Anesthesiologists
Pplato:Plato Pressure
Ppeak:Peak Pressure
Pmean:Mean Pressure
Pdriving:Driving Pressure
HR:Heart Rate
MAP:Mean Arterial Pressure
Scientific Title
THE EFFECTS OF PROTECTIVE MECHANICAL VENTILATION TECHNIQUES ON RESPIRATORY DYNAMICS, HEMODYNAMICS AND BLOOD GAS PARAMETERS FOR NEUROSURGERY CASES IN PRONE POSITION
Scientific Title:Acronym
PEEP:Positive End-Expiratory Pressure
ASA:American Society of Anesthesiologists
Pplato:Plato Pressure
Ppeak:Peak Pressure
Pmean:Mean Pressure
Pdriving:Driving Pressure
HR:Heart Rate
MAP:Mean Arterial Pressure
Region
| Europe |
Condition
Condition
In our study, the application of protective mechanical ventilation techniques in prone-position neurosurgery cases was targeted, with the goal of providing better oxygenation and ventilation in patients through personalized PEEP (Positive End-Expiratory Pressure) application compared to fixed PEEP. It was anticipated that by monitoring driving pressure and compliance parameters and determining personalized PEEP values, the risk of postoperative pulmonary complications could be reduced.
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determining the effects of protective mechanical ventilation techniques on respiratory dynamics, hemodynamics and blood gas parameters in prone neurosurgery cases and to determine the optimum positive end-expiratory pressure (PEEP) values by applying stepped PEEP values.
Basic objectives2
Others
Basic objectives -Others
Determining the effects of protective mechanical ventilation techniques on respiratory dynamics, hemodynamics and blood gas parameters in prone neurosurgery cases and to determine the optimum positive end-expiratory pressure (PEEP) values by applying stepped PEEP values.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the prone position, Pplato and Ppeak values were found to be higher in the P10 group compared to the other groups. The lowest Pmean value was found in the P5 group and the highest was in the P10 group. Pdriving value was higher in the P5 group than in the P10 and D groups. The mean PEEP value, which was determined by applying stepped PEEP in Group D, was found to be 7.41. A significant increase in Pplato and Ppeak values along with a significant decrease in compliance values were detected in all groups when transitioning from the supine position to the prone position. When the blood gas data was analyzed pH values were within normal limits in all cases and no clinically significant differences were found. While a significant decrease was observed in HR and MAP values in all groups by switching to the supine position, there were no significant changes in these parameters between the groups. In terms of the data evaluated in all three groups, no significant difference was found in terms of postoperative pulmonary complications.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
5 fixed PEEPs were applied to the 1st group
Interventions/Control_2
10 fixed PEEPs to the 2nd group
Interventions/Control_3
PEEP was applied gradually increasing to the 3rd group. For the 3rd group the PEEP with the lowest driving pressure and highest compliance were determined as the most appropriate value for the patient
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients at or over 18 years old without lung disease who will undergo elective neurosurgery in the prone position for at least 2 hours, with ASA (American Society of Anesthesiologists) classifications of ASA 1 and ASA 2.
Key exclusion criteria
Patients under 18 years old, excluding those with ASA classifications of ASA 1 and ASA 2, as well as patients with serious lung diseases and morbidly obese patients, who are taken into emergency surgery.
Target sample size
113
Research contact person
Name of lead principal investigator
| 1st name | Kubra |
| Middle name | |
| Last name | Bolat Gursoy |
Organization
Health Sciences University Istanbul Training and Research Hospital
Division name
Department of Anesthesiology and Reanimation
Zip code
34093
Address
Cerrahpasa Mah, Org. Abdurrahman Nafiz Gurman Cd. No.24, 34098 Fatih/Istanbul
TEL
00902124596000
kubrabolat7@gmail.com
Public contact
Name of contact person
| 1st name | Kubra |
| Middle name | |
| Last name | Bolat Gursoy |
Organization
Health Sciences University Istanbul Training and Research Hospital
Division name
Department of Anesthesiology and Reanimation
Zip code
34093
Address
Cerrahpasa Mah, Org. Abdurrahman Nafiz Gurman Cd. No.24, 34098 Fatih/Istanbul
TEL
00902124596000
Homepage URL
kubrabolat7@gmail.com
Sponsor or person
Institute
Health Sciences University Istanbul Training and Research Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Sciences University Istanbul Training and Research 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
Health Sciences University Istanbul Training and Research Hospital
Address
Cerrahpasa Mah, Org. Abdurrahman Nafiz Gurman Cd. No.24, 34098 Fatih/Istanbul
Tel
00902124596000
kubrabolat7@gmail.com
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 | 03 | Month | 26 | 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
113
Results
The application of individual-specific PEEP values did not cause any change in the hemodynamics of the cases, blood gas data or an increase in postoperative pulmonary complications when compared with the application of fixed 5 or fixed 10 PEEPs, apart from the conventional values in the application of protective mechanical ventilation.
Results date posted
| 2024 | Year | 03 | Month | 26 | Day |
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
| 2019 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 05 | 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 | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061603
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