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

Not Applicable

Active, not recruiting

• Conditions: Laparoscopic Surgeries
• Interventions: Device: volume controlled ventilation; Device: flow controlled ventilation

• Registration Number: NCT06274372
• Lead Sponsor: Derince Training and Research Hospital

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.

Study Timeline

• Study First Submitted: 2023-01-24
• Study Start: 2023-08-07
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-08-06
• Study Completion: 2024-08-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	volume controlled ventilation	patients ventilated with volume controlled ventilation
flow controlled ventilation	flow controlled ventilation	patients ventilated with flow controlled ventilation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kocaeli Derince Training and Research Hospital; 🇹🇷 Derince, Kocaeli, Turkey