Haemodynamic and Respiratory Effects of Volume-Controlled Versus Pressure-Controlled Ventilation During Gynecologic Surgery

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000626561
• Date of registration: 16/06/2015
• Prospective Registration: Yes
• Primary sponsor: Sariyer Hamidiye Etfal Training and Research Hospital
• 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
• Date of first enrolment: 03/06/2019
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12615000626561.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: Dr NESRIN AHU ASLAN

• Name: Dr NESRIN AHU ASLAN

Key inclusion & exclusion criteria

Inclusion criteria: ASA physical status I-II
Robotic gynaecologic surgery patients
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

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

ENDOMETRIUM CARCINOMA;CERVIX CARCINOMA;MYOMA UTERI;UTERINE PROLAPSUS;
ENDOMETRIUM CARCINOMA
CERVIX CARCINOMA
MYOMA UTERI
UTERINE PROLAPSUS

Surgery - Other surgery

Intervention(s)

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.

Primary Outcome(s)

Cardiac output by using picco[Baseline (t-zero)
After pneumoperitoneum (t1)
After 45 degree trendelenburg (t2)
15 (t3), 45 (t4), 90 (t5) minutes later
End of surgery (t6)]

Mean peak airway pressure
Lower peak airway pressure levels are expected on respiratory monitor[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(s)

Arterial carbondioxide level by arterial blood gas analysis[Baseline (t-zero)
After pneumoperitoneum (t1)
After 45 degree trendelenburg (t2)
15 (t3), 45 (t4), 90 (t5) minutes later
End of surgery (t6)]

Secondary ID(s)

NONE

Secondary Sponsor(s)

Not applicable

Ethics review

Status: Approved
Approval date:
Contact:

Istanbul Medipol University Interventional Clinical Trials Ethics Commitee