Skip to main content
Clinical Trials/NCT06274372
NCT06274372
Active, not recruiting
Not Applicable

The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, Prospective Randomized Study

Derince Training and Research Hospital1 site in 1 country30 target enrollmentAugust 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopic Surgeries
Sponsor
Derince Training and Research Hospital
Enrollment
30
Locations
1
Primary Endpoint
effects of flow controlled ventilation on arterial pressure
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations.

Detailed Description

Study will begin after ethics committee approval and the patient's written and verbal consent . Prospective observational studies will be conducted on patients over the age of 18 who will undergo laparoscopic surgery in the operating rooms. Patients who did not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD will be excluded. Patients will be randomized and divided into two groups. Patients intraoperatively ventilated with a conventional ventilator (GE™ Avance™ CS2, VCV mode) Group 1, intraoperative ventilation Ventinova ( Evone®, Ventinova Medical, Eindhoven, the Netherlands, FCV mode) will be referred to as Group 2. Standard monitoring (ECG; SpO2, end tidal CO2,arterial blood pressure) will be applied to all patients. Anesthesia induction will be performed with propofol, fentanyl, rocuronium bromide as standard; In addition, anesthesia maintenance of the patients will be provided with propofol and remifentanil. Respiratory parameters such as peripheral SpO2, PaCO2 value, peak airway pressure of each group will be recorded, and intraoperative hemodynamic parameters (systolic, diastolic, mean blood pressure, heart rate) of each group will be monitored and recorded. Postoperative respiratory functions and length of hospital stay of all patients will be monitored and recorded.

Registry
clinicaltrials.gov
Start Date
August 7, 2023
End Date
August 6, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Derince Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nurseda Dundar

Principal Investigator

Derince Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • patients who will undergo laparoscopic surgeries, ASA 1,2,3 physical status

Exclusion Criteria

  • patients who do not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD

Outcomes

Primary Outcomes

effects of flow controlled ventilation on arterial pressure

Time Frame: intraoperatively

Arterial blood pressure in mmHg

effectcs of flow controlled ventiletion on endtidal CO2

Time Frame: intraoperatively

endtidal CO2 in mmHg

effects of flow controlled ventilation on mean arterial pressure

Time Frame: intraoperatively

mean arterial pressure change in percent

effectcs of flow controlled ventiletion on peak airway pressure

Time Frame: intraoperatively

peak airway pressure in cmH2O

effects of flow controlled ventilation on heart rate

Time Frame: intraoperatively

heart rate in bpm

Secondary Outcomes

  • respiratory related complications(intraoperative period and postoperative first week)

Study Sites (1)

Loading locations...

Similar Trials