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

NCT ID: NCT06274372

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2024-08-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Laparoscopic Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

patients ventilated with volume controlled ventilation

Group Type OTHER

volume controlled ventilation

Intervention Type DEVICE

effects of volume controlled ventilation

flow controlled ventilation

patients ventilated with flow controlled ventilation

Group Type EXPERIMENTAL

flow controlled ventilation

Intervention Type DEVICE

effects of flow controlled ventilation

Interventions

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flow controlled ventilation

effects of flow controlled ventilation

Intervention Type DEVICE

volume controlled ventilation

effects of volume controlled ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nurseda Dundar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurseda Dundar, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli City Hospital

Locations

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Kocaeli Derince Training and Research Hospital

Derince, Kocaeli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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FCV,V-2202

Identifier Type: -

Identifier Source: org_study_id

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