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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

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

laparoscopic surgery

gynecologic malignancies

Condition category

Condition code

Anaesthesiology

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]

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]

Change in peak inspiratory pressure (PIP)by using the ventilator pressure manometer during the respiratory cycle

Timepoint [1]

Primary Timepoint: 5 minutes, 30 minutes and 60 minutesafter pneumoperitoneum and trandelenburg position

Primary outcome [2]

Change in mean inspiratory pressure (Pmean) by using the ventilator pressure manometer during the respiratory cycle

Timepoint [2]

Primary Timepoint: 5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position

Primary outcome [3]

Change in dynamic compliance by using the ventilator pressure manometer during the respiratory cycle

Timepoint [3]

Primary Timepoint: 5 minutes, 30 minutes and 60 minutes after pneumoperitoneum and trandelenburg position

Secondary outcome [1]

Change in PaO2 by using the arterial blood gas analysis

Timepoint [1]