Fluid ResponsivenessNCT04060069
Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness
An observational study of Fluid Responsiveness, run by Kocaeli University.
Trial summary
The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- Ringer Lactate
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Jul 2017
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 45 patients over the age of 18 who would undergo elective laparoscopic gynecological surgery and had the ASA (American Society of Anesthesiologists) risk classification I-II were included in the study.
Who may be able to join
- Age>18 years old patients
- Will undergo elective laparoscopic gynecological surgery
- ASA I-II
Who cannot join
- Obese patients (body mass index> 30 kg.m2)
- Patients who had arrhythmia
- Patients who had cardiac insufficiency.
About this study
Official title: Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery
The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.
Read the detailed description
After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.
- Conditions
- Fluid Responsiveness
- Being tested
- Ringer Lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer LactateOther
Fluids
| Study group | Role | What they receive |
|---|---|---|
| Before pneumoperitoneum | Fluid administration Receives: Other: Ringer Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum
to evaluate reliability of stroke volume variation in evaluating the response to fluid administration
Measured: up to 10 months
to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum
to evaluate reliability of pulse pressure variation in evaluating the response to fluid administration
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Oct 2016
- Primary completion1 Jun 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulay Sahin, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060069
- Sponsor's protocol ID
- KOU GOKAEK 2016/272
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT04060069
- Acronym / sponsor ID
- KOU GOKAEK 2016/272
- Conditions
- Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 16 Aug 2019 (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.
The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.
Detailed description
After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before pneumoperitoneum | – | Other: Ringer LactateFluid administration |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45 patients over the age of 18 who would undergo elective laparoscopic gynecological surgery and had the ASA (American Society of Anesthesiologists) risk classification I-II were included in the study.
Key inclusion criteria (3 listed)
- Age>18 years old patients
- Will undergo elective laparoscopic gynecological surgery
- ASA I-II
Key exclusion criteria (3 listed)
- Obese patients (body mass index> 30 kg.m2)
- Patients who had arrhythmia
- Patients who had cardiac insufficiency.
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 |
|---|---|---|
| Ringer LactateFluids | Other | Before pneumoperitoneum |
Primary outcome
to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum
Time frame: up to 10 months
to evaluate reliability of stroke volume variation in evaluating the response to fluid administration
to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum
Time frame: up to 10 months
to evaluate reliability of pulse pressure variation in evaluating the response to fluid administration
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 16 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Responsiveness, run by Kocaeli University.
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 3 inclusion and 3 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 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum (time frame: up to 10 months). The study lists 2 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 16 Aug 2019.