Laparoscopic SurgeriesNCT06274372
The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries
A study of Laparoscopic Surgeries, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgeries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2023to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Derince Training and Research Hospital
Derince, Kocaeli, 41900
About this study
Official title: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, Prospective Randomized Study
It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations.
Read the 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.
- Conditions
- Laparoscopic Surgeries
- Being tested
- flow controlled ventilation, volume controlled ventilation
- Keywords
- flow controlled ventilation, laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow controlled ventilationDevice
effects of flow controlled ventilation
volume controlled ventilationDevice
effects of volume controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | patients ventilated with volume controlled ventilation Receives: Device: volume controlled ventilation |
| flow controlled ventilation | Experimental | patients ventilated with flow controlled ventilation Receives: Device: flow controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of flow controlled ventilation on arterial pressure
Arterial blood pressure in mmHg
Measured: intraoperatively
effectcs of flow controlled ventiletion on endtidal CO2
endtidal CO2 in mmHg
Measured: intraoperatively
effects of flow controlled ventilation on mean arterial pressure
mean arterial pressure change in percent
Measured: intraoperatively
effects of flow controlled ventilation on heart rate
heart rate in bpm
Measured: intraoperatively
effectcs of flow controlled ventiletion on peak airway pressure
peak airway pressure in cmH2O
Measured: intraoperatively
Secondary outcomes (1)
respiratory related complications
rate of ventilator-associated pneumonia, rate of postoperative atelectasis, respiratory distress requiring reintubation by percentage.
Measured: intraoperative period and postoperative first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start7 Aug 2023
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurseda Dundar, Derince Training and Research Hospital
- Investigators
- Nurseda Dundar, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274372
- Sponsor's protocol ID
- FCV,V-2202
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2023
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06274372
- Acronym / sponsor ID
- FCV,V-2202
- Conditions
- Laparoscopic Surgeries
- Keywords
- flow controlled ventilation, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Device: volume controlled ventilationpatients ventilated with volume controlled ventilation |
| flow controlled ventilation | Experimental | Device: flow controlled ventilationpatients ventilated with flow controlled ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flow controlled ventilationeffects of flow controlled ventilation | Device | flow controlled ventilation |
| volume controlled ventilationeffects of volume controlled ventilation | Device | control group |
Primary outcome
effects of flow controlled ventilation on arterial pressure
Time frame: intraoperatively
Arterial blood pressure in mmHg
effectcs of flow controlled ventiletion on endtidal CO2
Time frame: intraoperatively
endtidal CO2 in mmHg
effects of flow controlled ventilation on mean arterial pressure
Time frame: intraoperatively
mean arterial pressure change in percent
effects of flow controlled ventilation on heart rate
Time frame: intraoperatively
heart rate in bpm
effectcs of flow controlled ventiletion on peak airway pressure
Time frame: intraoperatively
peak airway pressure in cmH2O
1 secondary outcome
respiratory related complications
Time frame: intraoperative period and postoperative first week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurseda Dundar, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Laparoscopic Surgeries, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of flow controlled ventilation on arterial pressure (time frame: intraoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.