General AnesthesiaNCT02771067
The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position
A study testing Fluid infusion in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Fluid infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2016to 23 Feb 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy
Who cannot join
- cardiac arrhythmia
- valvular heart disease
- ischemic heart disease
- left ventricular ejection fraction less than 40%
- Pulmonary disease
- esophageal disease
- upper gastrointestinal bleeding
- Body mass index more than 40 kg/m2.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Seoul, 120-752
About this study
The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.
- Conditions
- General Anesthesia
- Being tested
- Fluid infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid infusionProcedure or surgery
Fluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion.
| Study group | Role | What they receive |
|---|---|---|
| Pulse pressure variation | Experimental | Pulse pressure variation will be recorded via an arterial catheter after anesthetic induction, before pneumoperitoneum, after pneumoperitoneum, before infusion of 6% hydroxyethyl starch, and after infusion of 6% hydroxyethyl starch. Stroke volume will be also measured to differentiate the fluid responders. Receives: Procedure: Fluid infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse pressure variation
Ability of pulse pressure variation to predict fluid responsiveness will be evaluated.
Measured: During the surgery. At Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start29 Sep 2016
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771067
- Sponsor's protocol ID
- 4-2016-0205
- Status last verified
- Dec 2017
- First submitted
- 4 May 2016
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position
- ClinicalTrials.gov ID
- NCT02771067
- Acronym / sponsor ID
- 4-2016-0205
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- 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 purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse pressure variation | Experimental | Procedure: Fluid infusionPulse pressure variation will be recorded via an arterial catheter after anesthetic induction, before pneumoperitoneum, after pneumoperitoneum, before infusion of 6% hydroxyethyl starch, and after infusion of 6% hydroxyethyl starch. Stroke volume will be also measured to differentiate the fluid responders. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy
Key exclusion criteria (8 listed)
- cardiac arrhythmia
- valvular heart disease
- ischemic heart disease
- left ventricular ejection fraction less than 40%
- Pulmonary disease
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 |
|---|---|---|
| Fluid infusionFluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion. | Procedure or surgery | Pulse pressure variation |
Primary outcome
Pulse pressure variation
Time frame: During the surgery. At Day 0.
Ability of pulse pressure variation to predict fluid responsiveness will be evaluated.
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 18 Dec 2017.
- Individual participant dataSharing planned: No. The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.
Related trials for General Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid infusion in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
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 8 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 18 Dec 2017. 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 South Korea. 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?
Pulse pressure variation (time frame: During the surgery. At Day 0.). 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 18 Dec 2017.