Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001281684
Ethics application status
Approved
Date submitted
4/07/2023
Date registered
8/12/2023
Date last updated
8/12/2023
Date data sharing statement initially provided
8/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of prone position on mechanical power in patients undergoning neurosurgical operations
Scientific title
Prone position and mechanical power under general anesthesia
Secondary ID [1] 310050 0
'Nil known'
Universal Trial Number (UTN)
U1111-1294-6202
Trial acronym
PPMPUGA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal neurosurgical pathologies 330580 0
prone position under general anesthesia 330581 0
Condition category
Condition code
Anaesthesiology 327418 327418 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The effect of prone position on mechanical power will be investigated in patients undergoing neurosurgical operations under general anesthesia in prone position. The patient is positioned in the prone position as follows: The table is in a flat position. The arms are extended above the patient's head. The chest wall is supported by rollers that run from the pubic area to the collarbone.The support is placed under the pelvis. Knees and elbows are supported by pillows. The legs are bent up to knee level. The head is turned sideways and supported by a pillow so that there is no pressure on the eyes and ears. The arms are rotated backwards at torso level.The table is inclined to reduce lumbar lordosis. A belt is placed between the subgluteal region and the legs to prevent the patient from slipping caudally or cephalad. Various abdominal supports are placed to prevent pressure on the abdomen, such as tightly wrapped parallelepipeds, adjustable metal frames covered with soft supports, quadrupedal frames and more.
Mechanical power refers to the energy delivered into the respiratory system and becomes particularly relevant during mechanical ventilation. Mechanical power is used to encapsulate potential lung injuries, such as barotrauma, atelectotrauma, and volutrauma, into a single value. These injuries often arise due to excessive pressure or volume changes within the lungs.
Several parameters are employed in determining mechanical power: tidal volume , driving pressure , peak pressure , flow rate , respiratory rate, and PEEP .
These data, recorded on the mechanical ventilation device and customized for the patient's condition, are analyzed using Gattinoni's formula for calculating mechanical power in volume-controlled ventilation:

MP = TIDAL VOLUME X RESPIRATORY RATE X 0.098 X [ P PEAK – 1/2(P PLATEAU-PEEP)]

This formula enables the calculation of mechanical power, providing insight into how much energy is imparted to the lungs and indicating the potential risk of damage.
Mechanical power will be calculated as:15 minutes after anesthesia induction in supine position, 15 minutes after positioning the patient to prone position, and with 1 hour intervals therafter until the end of surgery and the last mechanical power calculations will be done at the end of the operation in prone position and concomittant with positioning the patient to supine before waking up the patient. Prone positioning will be done by the operation room personnel under the control of the anesthesiologist responsible for the care of the patient.
Intervention code [1] 326457 0
Early Detection / Screening
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335285 0
the primary outcome of the study is to compare the mechanical power applied to the respiratory system throughout the surgical period in patients undergoing neurosurgical operations in prone position.
Several parameters are employed in determining mechanical power: tidal volume , driving pressure , peak pressure, flow rate , respiratory rate, and PEEP .
These data, recorded on the mechanical ventilation device and customized for the patient's condition, are analyzed using Gattinoni's formula for calculating mechanical power in volume-controlled ventilation:

MP = TIDAL VOLUME X RESPIRATORY RATE X 0.098 X [ P PEAK – 1/2(P PLATEAU-PEEP)]
Timepoint [1] 335285 0
Data measurements and recordings will be taken at the following time points: 15 minutes after anesthesia induction in supine position(primary timepoint), 15 minutes after transitioning to the prone position, every hour during the operation, and 15 minutes after returning to supine position at the end of the surgery. Calculations will conclude after data has been recorded in the supine position
Secondary outcome [1] 423736 0
determining the effect of demographical data of the patients on mechanical power in patients undergoing neurosurgical operations in prone postion.
Demographic data such as age, gender, height, weight, and parameters like ASA score, additional medical conditions, and smoking status will be recorded. These parameters will be obtained from the hospital's record system
Timepoint [1] 423736 0
Starting with the patients' signing up to the study and fifteen minutes after being placed in the prone position and every hour thereafter are the secondary timepoints of the study.
Secondary outcome [2] 423737 0
determining the effect of patient temperature on mechanical power in patients undergoing neurosurgical operations in prone postion.The patient's temperature measurement was performed using an infrared forehead thermometer.
Timepoint [2] 423737 0
Temperature measurement will be conducted during the time intervals when mechanical power is assessed. Measurements will occur 15 minutes after anesthesia induction in the supine position, 15 minutes after transitioning to the prone position, every hour during the operation, and at the end of the surgery when the patient is returned to the supine position.

Eligibility
Key inclusion criteria
patients undergoing neurosurgical operations in prone position aged 18-100 years with American Society of Anesthesiologist(ASA) physical classification score between ASA I - ASAIII,
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal to be involved in the study, ASA physical classification score> III, patients with known organ insufficiency, patients with a history of prior respiratory system surgery, and morbid obesity.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The present study is designed as a prospective observational study. The data collection time interval will be three months with an expected patient number of 60 patients. The data collected will be analysed with IBM SPSS package program. the results will be presented as means, madians, percentiles as applicable

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25622 0
Turkey
State/province [1] 25622 0
Zonguldak

Funding & Sponsors
Funding source category [1] 314600 0
Self funded/Unfunded
Name [1] 314600 0
Berrrak Sebil Aydin
Country [1] 314600 0
Turkey
Primary sponsor type
Individual
Name
Berrak Sebil Aydin
Address
Ömerli, Kaynarca Cd. No:309, 67300 Eregli/Zonguldak
Country
Turkey
Secondary sponsor category [1] 316148 0
None
Name [1] 316148 0
Address [1] 316148 0
Country [1] 316148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313340 0
Zonguldak Bülent Ecevit Üniversitesi Girisimsel Olmayan Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 313340 0
Ethics committee country [1] 313340 0
Turkey
Date submitted for ethics approval [1] 313340 0
04/05/2023
Approval date [1] 313340 0
14/06/2023
Ethics approval number [1] 313340 0
2023-12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127798 0
Dr Berrak Sebil Aydin
Address 127798 0
Karadeniz Eregli Devlet Hastanesi, Eregli, Zonguldak, Turkey, 67300
Country 127798 0
Turkey
Phone 127798 0
+905058178141
Fax 127798 0
Email 127798 0
[email protected]
Contact person for public queries
Name 127799 0
Berrak Sebil Aydin
Address 127799 0
Karadeniz Eregli Devlet Hastanesi, Eregli, Zonguldak, Turkey, 67300
Country 127799 0
Turkey
Phone 127799 0
+905058178141
Fax 127799 0
Email 127799 0
[email protected]
Contact person for scientific queries
Name 127800 0
Berrak Sebil Aydin
Address 127800 0
Karadeniz Eregli Devlet Hastanesi, Eregli, Zonguldak, Turkey, 67300
Country 127800 0
Turkey
Phone 127800 0
+905058178141
Fax 127800 0
Email 127800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to regional laws regarding the 'personal data protection' in Turkey.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.