The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries

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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgeries
• Intervention / Treatment: Device: volume controlled ventilation; Device: flow controlled ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli
    • Derince, Kocaeli, Turkey, 41900
      • Kocaeli Derince Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; patients ventilated with volume controlled ventilation	Device: volume controlled ventilation; effects of volume controlled ventilation
Experimental: flow controlled ventilation; patients ventilated with flow controlled ventilation	Device: flow controlled ventilation; effects of flow controlled ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects of flow controlled ventilation on arterial pressure	Arterial blood pressure in mmHg	intraoperatively
effectcs of flow controlled ventiletion on endtidal CO2	endtidal CO2 in mmHg	intraoperatively
effects of flow controlled ventilation on mean arterial pressure	mean arterial pressure change in percent	intraoperatively
effects of flow controlled ventilation on heart rate	heart rate in bpm	intraoperatively
effectcs of flow controlled ventiletion on peak airway pressure	peak airway pressure in cmH2O	intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory related complications	rate of ventilator-associated pneumonia, rate of postoperative atelectasis, respiratory distress requiring reintubation by percentage.	intraoperative period and postoperative first week

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital
• Investigators: Principal Investigator: Nurseda Dundar, MD, Kocaeli City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopy; flow controlled ventilation
• Other Study ID Numbers: FCV,V-2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No