Clinical trial NCT06274372: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries
Official title: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgeries
Keywords: flow controlled ventilation
laparoscopy
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria: patients who will undergo laparoscopic surgeries, ASA 1,2,3 physical status

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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

Primary outcomes:
measure: effects of flow controlled ventilation on arterial pressure
timeFrame: intraoperatively
measure: effectcs of flow controlled ventiletion on endtidal CO2
timeFrame: intraoperatively
measure: effects of flow controlled ventilation on mean arterial pressure
timeFrame: intraoperatively
measure: effects of flow controlled ventilation on heart rate
timeFrame: intraoperatively
measure: effectcs of flow controlled ventiletion on peak airway pressure
timeFrame: intraoperatively
Secondary outcomes:
measure: respiratory related complications
timeFrame: intraoperative period and postoperative first week
Other outcomes:
Locations:
city: Derince
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
state: Kocaeli
Study officials:
affiliation: Kocaeli City Hospital
name: Nurseda Dundar, MD
role: PRINCIPAL_INVESTIGATOR
References: