Respiration, ArtificialNCT03684291
Hemodynamic Effects of Ventilation Modes
An observational study of Respiration, Artificial and Laparoscopy, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Different ventilation modes can be used in laparoscopic surgeries. These surgeries are performed in steep Trendelenburg position with serious hemodynamic disturbances. This study aims to observe the hemodynamic effects of two different ventilation modes in laparoscopic gynecologic surgery performed in steep… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Respiration, Artificial, Laparoscopy, Hemodynamics
- What is being tested?
- Mode of Mechanical Ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 15 Nov 2018
- Phase
- Observational
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women between 18 and 65 years of age scheduled to undergo elective gynecologic laparoscopic surgery
Who may be able to join
- Women of ASA I and II classification between 18-65 years scheduled for elective gynecologic laparoscopic surgery
Who cannot join
- Patient refusal to participate
- Patients with severe cardiac (congestive heart failure etc) and pulmonary (COPD, pulmonary hypertension) disease (ASA > III)
- Morbid obesity
- Negative Allen test
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ufuk University Faculty of Medicine
Ankara, Balgat, 06520
Hakan Yılmaz, MD, +903122044000, dr.hakanyilmaz@hotmail.com
Hakan Yılmaz, MD
About this study
Official title: Effects of Two Different Ventilation Modes Used in Gynecologic Laparoscopic Operations Performed in Steep Trendelenburg Position on Hemodynamic Parameters
Different ventilation modes can be used in laparoscopic surgeries. These surgeries are performed in steep Trendelenburg position with serious hemodynamic disturbances. This study aims to observe the hemodynamic effects of two different ventilation modes in laparoscopic gynecologic surgery performed in steep Trendelenburg position.
- Conditions
- Respiration, Artificial, Laparoscopy, Hemodynamics
- Being tested
- Mode of Mechanical Ventilation
- Keywords
- Mechanical ventilation, Laparoscopic surgery, Hemodynamics
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mode of Mechanical VentilationProcedure or surgery
Adjustment of mechanical ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| Group V | The patients in this group are ventilated using VCV (Volume Control Ventilation) mode (FiO2 50%, Tidal volume: 6-8 ml/kg (ideal body weight), frequency: 12/minute, I/E ratio: 1/2, PEEP not applied) Receives: Procedure: Mode of Mechanical Ventilation | |
| Group P | The patients in this group are ventilated using PCV-VG (Volume Guaranteed Pressure Control Ventilation) mode (FiO2 50%, Tidal volume: 6-8 ml/kg (ideal body weight), frequency: 12/minute (EtCO2 kept between 35-40 mmHg), Pressure limit: 30 cm H2O, I/E:1/2, PEEP not applied) Receives: Procedure: Mode of Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of changes in MAP
Mean arterial pressure (MAP) (mmHg)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in heart rate
Heart rate (bpm)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in systemic vascular resistance index
Systemic vascular resistance index (dyne x sec/cm2)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in stroke volume index
Stroke volume index (mL/m2)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in cardiac index
Cardiac index L(min x m2)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in stroke volume variation
Stroke volume variation (%)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in cardiac cycle efficiency
Cardiac cycle efficiency (units)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in aortic dp/dt
Aortic dP/dt (mmHg/msec)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Secondary outcomes (3)
Measurement of changes in peak airway pressure
Ppeak (Peak airway pressure)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in mean airway pressure
Pmean (Mean Airway Pressure),
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in plateau airway pressure
Pplateau (Plateau Airway Pressure)
Measured: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion15 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Yılmaz, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684291
- Sponsor's protocol ID
- HemodynamicsTrendelenburg
- Status last verified
- Sep 2018
- First submitted
- 15 Jan 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balderi T, Forfori F, Marra V, Di Salvo C, Dorigo M, Anselmino M, Romano SM, Giunta F. Continuous hemodynamic monitoring during laparoscopic gastric bypass in superobese patients by pressure recording analytical method. Obes Surg. 2008 Aug;18(8):1007-14. doi: 10.1007/s11695-007-9379-5. Epub 2008 Apr 15.
PubMed 18414959Liao CC, Kau YC, Ting PC, Tsai SC, Wang CJ. The Effects of Volume-Controlled and Pressure-Controlled Ventilation on Lung Mechanics, Oxidative Stress, and Recovery in Gynecologic Laparoscopic Surgery. J Minim Invasive Gynecol. 2016 Mar-Apr;23(3):410-7. doi: 10.1016/j.jmig.2015.12.015. Epub 2016 Jan 7.
PubMed 26772778
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Ventilation Modes Used in Gynecologic Laparoscopic Operations Performed in Steep Trendelenburg Position on Hemodynamic Parameters
- ClinicalTrials.gov ID
- NCT03684291
- Acronym / sponsor ID
- HemodynamicsTrendelenburg
- Conditions
- Respiration, Artificial, Laparoscopy, Hemodynamics
- Keywords
- Mechanical ventilation, Laparoscopic surgery, Hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 15 Nov 2018 (estimated)
- First posted
- 25 Sep 2018 (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.
Different ventilation modes can be used in laparoscopic surgeries. These surgeries are performed in steep Trendelenburg position with serious hemodynamic disturbances. This study aims to observe the hemodynamic effects of two different ventilation modes in laparoscopic gynecologic surgery performed in steep Trendelenburg position.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group V | – | Procedure: Mode of Mechanical VentilationThe patients in this group are ventilated using VCV (Volume Control Ventilation) mode (FiO2 50%, Tidal volume: 6-8 ml/kg (ideal body weight), frequency: 12/minute, I/E ratio: 1/2, PEEP not applied) |
| Group P | – | Procedure: Mode of Mechanical VentilationThe patients in this group are ventilated using PCV-VG (Volume Guaranteed Pressure Control Ventilation) mode (FiO2 50%, Tidal volume: 6-8 ml/kg (ideal body weight), frequency: 12/minute (EtCO2 kept between 35-40 mmHg), Pressure limit: 30 cm H2O, I/E:1/2, PEEP not applied) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women between 18 and 65 years of age scheduled to undergo elective gynecologic laparoscopic surgery
Key inclusion criteria (1 listed)
- Women of ASA I and II classification between 18-65 years scheduled for elective gynecologic laparoscopic surgery
Key exclusion criteria (4 listed)
- Patient refusal to participate
- Patients with severe cardiac (congestive heart failure etc) and pulmonary (COPD, pulmonary hypertension) disease (ASA > III)
- Morbid obesity
- Negative Allen test
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 |
|---|---|---|
| Mode of Mechanical VentilationAdjustment of mechanical ventilation mode | Procedure or surgery | Group P, Group V |
Primary outcome
Measurement of changes in MAP
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Mean arterial pressure (MAP) (mmHg)
Measurement of changes in heart rate
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Heart rate (bpm)
Measurement of changes in systemic vascular resistance index
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Systemic vascular resistance index (dyne x sec/cm2)
Measurement of changes in stroke volume index
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Stroke volume index (mL/m2)
Measurement of changes in cardiac index
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Cardiac index L(min x m2)
Measurement of changes in stroke volume variation
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Stroke volume variation (%)
Measurement of changes in cardiac cycle efficiency
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Cardiac cycle efficiency (units)
Measurement of changes in aortic dp/dt
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Aortic dP/dt (mmHg/msec)
3 secondary outcomes
Measurement of changes in peak airway pressure
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in mean airway pressure
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in plateau airway pressure
Time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Background: PubMed 18414959Balderi T, Forfori F, Marra V, Di Salvo C, Dorigo M, Anselmino M, Romano SM, Giunta F. Continuous hemodynamic monitoring during laparoscopic gastric bypass in superobese patients by pressure recording analytical method. Obes Surg. 2008 Aug;18(8):1007-14. doi: 10.1007/s11695-007-9379-5. Epub 2008 Apr 15.
- Background: PubMed 26772778Liao CC, Kau YC, Ting PC, Tsai SC, Wang CJ. The Effects of Volume-Controlled and Pressure-Controlled Ventilation on Lung Mechanics, Oxidative Stress, and Recovery in Gynecologic Laparoscopic Surgery. J Minim Invasive Gynecol. 2016 Mar-Apr;23(3):410-7. doi: 10.1016/j.jmig.2015.12.015. Epub 2016 Jan 7.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial and Laparoscopy, run by Ufuk University 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perihan Ekmekçi, MD (+903122044000 ext. 4424, erdogduperi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of changes in MAP (time frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684291, which also lists 2 linked publications.
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 25 Sep 2018; AzTrials last refreshed its copy on 3 Nov 2026.