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Trial registered on ANZCTR


Registration number
ACTRN12615000626561
Ethics application status
Approved
Date submitted
14/04/2015
Date registered
16/06/2015
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Haemodynamic and Respiratory Effects of Volume-Controlled Versus Pressure-Controlled Ventilation During Gynecologic Surgery
Scientific title
Haemodynamic and Respiratory Effects of Volume-Controlled Versus Pressure-Controlled Ventilation During Gynecologic Laparoscopic Surgery in Steep Trendelenburg Position
Secondary ID [1] 286528 0
NONE
Universal Trial Number (UTN)
U1111-1169-2536
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ENDOMETRIUM CARCINOMA 294747 0
CERVIX CARCINOMA 295031 0
MYOMA UTERI 295032 0
UTERINE PROLAPSUS 295033 0
Condition category
Condition code
Anaesthesiology 295033 295033 0 0
Other anaesthesiology
Surgery 295208 295208 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mechanical ventilation mode:
PCV is an alternative mode of ventilation to VCV that is widely used in patients with elevated intraabdominal pressure and it has been shown to improve arterial oxygenation and decrease the peak airway pressure because of its decelerating inspiratory flow.

Mechanical ventilation will be administered continuously from induction of anesthesia until extubation. In the pressure-controlled group, the peak airway pressure not exceeding 35 cmH2O will be set to provide a tidal volume of 8 ml/kg, with and I:E ratio of 1:1,5. The respiratory rate will be adjusted to obtain an end-tidal CO2 of 35-40 cmH2O to be started with a respiratory rate of 12/min.
Intervention code [1] 291617 0
Treatment: Devices
Comparator / control treatment
VCV is considered as a control
Mechanical ventilation will be administered continuously from induction of anesthesia until extubation.
In the volume controlled group, the ventilation will be started with a tidal volume of 8 ml/kg and the initial tidal volume will be increased by 1 mL/kg every 5 minutes until 12 mL/kg. Respiratory rate will initially be set to 12/min with an I:E ratio of 1:1,5 and will be increased by 2/min every 5 min till 20/min to maintain an end-tidal CO2 between 35-40 mmHg.
Control group
Active

Outcomes
Primary outcome [1] 294793 0
Mean peak airway pressure
Lower peak airway pressure levels are expected on respiratory monitor
Timepoint [1] 294793 0
Baseline (t-zero)
After pneumoperitoneum (t1)
After 45 degree trendelenburg (t2)
15 (t3), 45 (t4), 90 (t5) minutes later
End of surgery (t6)
Primary outcome [2] 294794 0
Cardiac output by using picco
Timepoint [2] 294794 0
Baseline (t-zero)
After pneumoperitoneum (t1)
After 45 degree trendelenburg (t2)
15 (t3), 45 (t4), 90 (t5) minutes later
End of surgery (t6)
Secondary outcome [1] 314061 0
Arterial carbondioxide level by arterial blood gas analysis
Timepoint [1] 314061 0
Baseline (t-zero)
After pneumoperitoneum (t1)
After 45 degree trendelenburg (t2)
15 (t3), 45 (t4), 90 (t5) minutes later
End of surgery (t6)

Eligibility
Key inclusion criteria
ASA physical status I-II
Robotic gynaecologic surgery patients
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Valvular heart disease
Abnormal regional wall contraction in echocardiography
Pericardial disease
Dilated cardiomyopathy
Left atrial dialtation
Left ventricular dilatation
Obstructive/restrictive lung disease
Body mass index>30
Eosophageal disease/dysphagia
Blood loss leading more than %10 decrease in MAP

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients are going to be randomly allocated to one of two groups using central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2019
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] 6810 0
Turkey
State/province [1] 6810 0
ISTANBUL

Funding & Sponsors
Funding source category [1] 291089 0
Self funded/Unfunded
Name [1] 291089 0
Country [1] 291089 0
Primary sponsor type
Hospital
Name
Sariyer Hamidiye Etfal Training and Research Hospital
Address
Kazim Karabekir Pasa Mahallesi
Bahcekoy Caddesi, No:62
34453
Sariyer
Istanbul
Turkey
Country
Turkey
Secondary sponsor category [1] 289768 0
None
Name [1] 289768 0
Not applicable
Address [1] 289768 0
Not applicable
Country [1] 289768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292671 0
Istanbul Medipol University Interventional Clinical Trials Ethics Commitee
Ethics committee address [1] 292671 0
Kavacik Mahallesi
Ekinciler Caddesi No:19
34810
Beykoz
Istanbul
Turkey
Ethics committee country [1] 292671 0
Turkey
Date submitted for ethics approval [1] 292671 0
26/12/2014
Approval date [1] 292671 0
30/12/2014
Ethics approval number [1] 292671 0
10840098-378

Summary
Brief summary
The aim of this stydy is to compare the effects of volume-controlled and pressure-controlled ventilation on cardiac output changes in patients undergoing robotic assisted gynecologic surgery in steep Trendelenburg position.
Hypothesis: PCV may be a more effective method for maintaining more stable haemodynamics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56518 0
Dr NESRIN AHU ASLAN
Address 56518 0
Zekeriyakoy Mahallesi
Basin Yayin Sitesi
Erguvan Sokak No:16
34450
Sariyer
Istanbul
Turkey
Country 56518 0
Turkey
Phone 56518 0
+90 532 3965678
Fax 56518 0
Email 56518 0
[email protected]
Contact person for public queries
Name 56519 0
NESRIN AHU ASLAN
Address 56519 0
Zekeriyakoy Mahallesi
Basin Yayin Sitesi
Erguvan Sokak No:16
34450
Sariyer
Istanbul
Turkey
Country 56519 0
Turkey
Phone 56519 0
+90 532 3965678
Fax 56519 0
Email 56519 0
[email protected]
Contact person for scientific queries
Name 56520 0
NESRIN AHU ASLAN
Address 56520 0
Zekeriyakoy Mahallesi
Basin Yayin Sitesi
Erguvan Sokak No:16
34450
Sariyer
Istanbul
Turkey
Country 56520 0
Turkey
Phone 56520 0
+90 532 3965678
Fax 56520 0
Email 56520 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
IPD will not provide any Scientific Contribution


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.