- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274372
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kocaeli
-
Derince, Kocaeli, Turkey, 41900
- Kocaeli Derince Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: control group
volume controlled ventilation
|
effects of volume controlled ventilation
|
Experimental: fcv
flow controlled ventilation
|
effects of flow controlled ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effects of flow controlled ventilation on heamodynamic parameters
Time Frame: intraoperatively
|
Arterial blood pressure in mmHg
|
intraoperatively
|
effectcs of flow controlled ventiletion on respiratory parameters
Time Frame: intraoperatively
|
endtidal CO2 in mmHg
|
intraoperatively
|
effects of flow controlled ventilation on heamodynamic parameters
Time Frame: intraoperatively
|
mean arterial pressure change in percent
|
intraoperatively
|
effects of flow controlled ventilation on heamodynamic parameters
Time Frame: intraoperatively
|
heart rate in bpm
|
intraoperatively
|
effectcs of flow controlled ventiletion on respiratory parameters
Time Frame: intraoperatively
|
peak airway pressure in cmH2O
|
intraoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
intraoperative period and postoperative first week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FCV,V-2202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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