Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000663257
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
24/04/2018
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Date results information initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ventilation during laparoscopic surgery in trandelenburg position
Scientific title
Comparison of pressure-controlled volume-guaranteed ventilation and volume-controlled ventilation in obese patients during gynecologic laparoscopic surgery in the Trendelenburg position
Secondary ID [1] 293965 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic surgery 307347 0
gynecologic malignancies
 307348 0
Condition category
Condition code
Anaesthesiology 306453 306453 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we are using a ventilation procedure for patients undergoing laparoscopic gynecologic malignancy procedures in trandelenburg position. The interventions will be delivered by the staff anesthesiologist.After induction and intubation before the initiation of surgery, patients will be assigned into two equal groups; VCV group and PCV-VG group. Ventilation settings in both groups will be
VT 8 mL/kg
Inspiratory/expiratory (I/E) ratio 1:2
Inspired oxygen concentration (FIO2) 0.5 with air
2.0 L/min of inspiratory fresh gas flow
No positive end-expiratory pressure (PEEP)
Respiratory rate (RR) was adjusted to maintain an endtidal of 35 ± 2 mmHg.
FiO2 0.4
CO2 pressure (ETCO2) of 35 ± 2 mmHg.
In the VCV group, the ventilator settings will be continued throughout the study. In the PCV- VG group, PCV-VG mode will be chosen to achieve VT 8 mL/kg, with RR will be adjusted to maintain ETCO2 35 ± 2 mmHg. The intraperitoneal pressure will be adjusted to 12 ± 2 mmHg,
and then 30° Trendelenburg position will be established.
Intervention code [1] 300861 0
Treatment: Other
Comparator / control treatment
Patients in group VCV. Ventilation settings in VCV group will be;
VT 8 mL/kg
Inspiratory/expiratory (I/E) ratio 1:2
Inspired oxygen concentration (FIO2) 0.5 with air
2.0 L/min of inspiratory fresh gas flow
No positive end-expiratory pressure (PEEP)
Respiratory rate (RR) was adjusted to maintain an endtidal of 35 ± 2 mmHg.
FiO2 0.4
CO2 pressure (ETCO2) of 35 ± 2 mmHg.
In the VCV group, the ventilator settings will be continued throughout the study. The concern of VCV is a different flow type as the constant flow that may cause high peak pressures and thus expose the patient to the risk of barotraumas.
Control group
Active

Outcomes
Primary outcome [1] 305478 0
Change in peak inspiratory pressure (PIP)by using the ventilator pressure manometer during the respiratory cycle
Timepoint [1] 305478 0
Primary Timepoint: 5 minutes, 30 minutes and 60 minutesafter pneumoperitoneum and trandelenburg position
Primary outcome [2] 305550 0
Change in mean inspiratory pressure (Pmean) by using the ventilator pressure manometer during the respiratory cycle
Timepoint [2] 305550 0
Primary Timepoint: 5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position
Primary outcome [3] 305551 0
Change in dynamic compliance by using the ventilator pressure manometer during the respiratory cycle
Timepoint [3] 305551 0
Primary Timepoint: 5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position
Secondary outcome [1] 345384 0
Change in PaO2 by using the arterial blood gas analysis
Timepoint [1] 345384 0
5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position
Secondary outcome [2] 345385 0
Change in mean arterial pressure by using blood pressure monitor on the anesthesia workstation
Timepoint [2] 345385 0
5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position
Secondary outcome [3] 345386 0
Change in heart rate by using electrocardiogram on the anesthesia workstation
Timepoint [3] 345386 0
5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position
Secondary outcome [4] 345718 0
Change in pH by using the arterial blood gas analysis
Timepoint [4] 345718 0
5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position
Secondary outcome [5] 345719 0
Change in PaCO2 by using the arterial blood gas analysis
Timepoint [5] 345719 0
5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position

Eligibility
Key inclusion criteria
Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical status I, II or III, BMI> 30 kg/m2 undergoing laparoscopic gynecologic malignancies surgery will be enrolled in the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients suspected as difficult intubation, and have severe obstructive or
restrictive pulmonary disease (defined as less than 50% of the predicted values of forced vital capacity and forced expiratory volume in 1 second) and body mass index < 30 kg/m2 will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Statistical methods / analysis
Data will be statistically described in terms of mean ± SD. Comparison between the study groups will done using Student t test for independent samples while within-group
comparison between the different time points was done using paired t test. Comparison of the different variables over the study time points will be done using repeated measure
analysis of variance through General Linear Model regression analysis with repeated measure and the paired t test was done as a post hoc test. P < .05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
28/06/2018
Date of last participant enrolment
Anticipated
1/10/2018
Actual
27/08/2018
Date of last data collection
Anticipated
Actual
27/08/2018
Sample size
Target
96
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 10279 0
Turkey
State/province [1] 10279 0
Mugla

Funding & Sponsors
Funding source category [1] 298597 0
Hospital
Name [1] 298597 0
Mugla Sitki Kocman University Training and Research Hospital
Country [1] 298597 0
Turkey
Primary sponsor type
Individual
Name
Melike Korkmaz Toker
Address
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country
Turkey
Secondary sponsor category [1] 297752 0
None
Name [1] 297752 0
Address [1] 297752 0
Country [1] 297752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299559 0
MUGLA SITKI KOCMAN UNIVERSITY CLINICAL TRIALS ETHICAL COMMITTEE
Ethics committee address [1] 299559 0
MUGLA SITKI KOCMAN UNIVERSITY CLINICAL TRIALS ETHICAL COMMITTEE. Mugla Sitki Kocman University Medical Faculty Dean Office 48001 MUGLA/TURKEY
Ethics committee country [1] 299559 0
Turkey
Date submitted for ethics approval [1] 299559 0
02/04/2018
Approval date [1] 299559 0
31/05/2018
Ethics approval number [1] 299559 0

Summary
Brief summary
Our aim is to analyze the effects of pressure-controlled ventilation-volume guaranteed (PCV-VG) and volume controlled ventilation (VCV) on airway pressures and respiratory and circulatory indicators during laparoscopic surgery in Trendelenburg position. This is a prospective randomized comparative clinical study. Patients will be randomly allocated to either VCV group (n = 48) or the PCV-VG group (n = 48). After induction of anesthesia, for both modes of ventilation, the target tidal volume (VT) will be 8 mL/kg and the respiratory rate will be adjusted to avoid hypercarbia. The peak and mean inspiratory pressures, dynamic compliance, exhaled VT and arterial blood gas parameters will be calculated and recorded after stabilization of pneumoperitoneum, T3 and T4, 30 and 60 minutes after 30° Trendelenburg position with pneumoperitoneum respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80834 0
Dr MELIKE KORKMAZ TOKER
Address 80834 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 80834 0
Turkey
Phone 80834 0
+905054747098
Fax 80834 0
Email 80834 0
[email protected]
Contact person for public queries
Name 80835 0
Dr Melike Korkmaz Toker
Address 80835 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 80835 0
Turkey
Phone 80835 0
+905054747098
Fax 80835 0
Email 80835 0
[email protected]
Contact person for scientific queries
Name 80836 0
A/Prof Basak Altiparmak
Address 80836 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 80836 0
Turkey
Phone 80836 0
+905326726533
Fax 80836 0
Email 80836 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
All of the individual participant data collected during the trial will not be shared due to patient data confidentiality we promised to local ethics committees.


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.