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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06274372
Enrollment
30
Registered
2024-02-23
Start date
2023-08-07
Completion date
2024-08-06
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Surgeries

Keywords

flow controlled ventilation, laparoscopy

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.

Interventions

effects of flow controlled ventilation

effects of volume controlled ventilation

Sponsors

Derince Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effects of flow controlled ventilation on arterial pressureintraoperativelyArterial blood pressure in mmHg
effectcs of flow controlled ventiletion on endtidal CO2intraoperativelyendtidal CO2 in mmHg
effects of flow controlled ventilation on mean arterial pressureintraoperativelymean arterial pressure change in percent
effects of flow controlled ventilation on heart rateintraoperativelyheart rate in bpm
effectcs of flow controlled ventiletion on peak airway pressureintraoperativelypeak airway pressure in cmH2O

Secondary

MeasureTime frameDescription
respiratory related complicationsintraoperative period and postoperative first weekrate of ventilator-associated pneumonia, rate of postoperative atelectasis, respiratory distress requiring reintubation by percentage.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026