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Completed

NCT Number: NCT06274372

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli Derince Training and Research Hospital

Derince, Kocaeli, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flow controlled ventilation

Device

effects of flow controlled ventilation

volume controlled ventilation

Device

effects of volume controlled ventilation

Primary outcomes

  1. effects of flow controlled ventilation on arterial pressure

    Time frame: intraoperatively

    Arterial blood pressure in mmHg

  2. effectcs of flow controlled ventiletion on endtidal CO2

    Time frame: intraoperatively

    endtidal CO2 in mmHg

  3. effects of flow controlled ventilation on mean arterial pressure

    Time frame: intraoperatively

    mean arterial pressure change in percent

  4. effects of flow controlled ventilation on heart rate

    Time frame: intraoperatively

    heart rate in bpm

  5. effectcs of flow controlled ventiletion on peak airway pressure

    Time frame: intraoperatively

    peak airway pressure in cmH2O

Secondary outcomes

  1. respiratory related complications

    Time frame: intraoperative period and postoperative first week

    rate of ventilator-associated pneumonia, rate of postoperative atelectasis, respiratory distress requiring reintubation by percentage.

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.