Gynecologic NeoplasmsNCT02653469
Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy
An observational study of Gynecologic Neoplasms and Abdominal Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gynecologic Neoplasms, Abdominal Neoplasms
- What is being tested?
- Augmented ventilation and Fluid loading
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Feb 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective open laparotomy surgery.
Who may be able to join
- Adult patients undergoing elective open laparotomy surgery.
Who cannot join
- Irregular heart beats,
- cardiac arrhythmia,
- moderate or severe valvular heart disease,
- preoperative left ventriular ejection fraction less than 40%,
- moderate t severe obstructive pulmonary disease,
- preoperative need of inotropics infusion,
Show all 12Show fewer
- preoperative serum Cr > 1.3ml/dl,
- moderate to severe renal or liver disease,
- acute lung injury or acute lung problem,
- coexisting open chest condition,
- severe bradycardia,
- patients with spontaneous breathing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery
Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.
- Conditions
- Gynecologic Neoplasms, Abdominal Neoplasms
- Being tested
- Augmented ventilation, Fluid loading
- Medical subject headings
- Genital Neoplasms, Female, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented ventilationOther
When the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration.
Fluid loadingOther
Also called Balanced crystalloid infusion
We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid
| Study group | Role | What they receive |
|---|---|---|
| Augmented ventilation with fluid loading | This is an observational study and as a diagnostic intervention, subjects in the study would receive mechanical ventilation with augmented tidal volume of 12ml/kg for 2min. Augmented ventilation is performed when the patient's PPV is within grey zone (9-13%). The investigators perform this procedure to every patients and do not assigh this intervention to the subjects of the study. Then, 6ml/kg of ballanced crystalloid loading will be infused to every patient. Receives: Other: Augmented ventilation; Other: Fluid loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness
Augmented ventilation (12ml/kg) will be performed when the participant's PPV is within grey zone (9-13%). PPV value will be collected automatically by Intelivue philips patient monitor. Percentage changes in stroke volume index by EV1000 according to fluid loading were used as principal indicators of fluid responsiveness. Patients were classified as responders or non-responders when increases in SVI were ≥ 10% or <10% after volume loading (crystalloid iv 6ml/kg). To test the abilities of augmented PPV to predict fluid responsiveness, areas under the receiver operating characteristics (ROC) curves of the responders [area under the curve (AUC) = 0.5: no better than chance, no prediction possible; AUC = 1.0: best possible prediction] will be calculated.
Measured: within 2 min from augmented ventilation
Secondary outcomes (1)
Conventional baseline PPV to predict fluid responsiveness
PPV value will be collected automatically by Intelivue philips patient monitor.
Measured: when patients PPV in grey zone, before augmented ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653469
- Sponsor's protocol ID
- SMC 2015-06-015
- Status last verified
- Mar 2016
- First submitted
- 20 Oct 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.
PubMed 28974059
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery
- ClinicalTrials.gov ID
- NCT02653469
- Acronym / sponsor ID
- SMC 2015-06-015
- Conditions
- Gynecologic Neoplasms, Abdominal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Jan 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.
Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented ventilation with fluid loading | – | Other: Augmented ventilation, Other: Fluid loadingThis is an observational study and as a diagnostic intervention, subjects in the study would receive mechanical ventilation with augmented tidal volume of 12ml/kg for 2min. Augmented ventilation is performed when the patient's PPV is within grey zone (9-13%). The investigators perform this procedure to every patients and do not assigh this intervention to the subjects of the study. Then, 6ml/kg of ballanced crystalloid loading will be infused to every patient. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective open laparotomy surgery.
Key inclusion criteria (1 listed)
- Adult patients undergoing elective open laparotomy surgery.
Key exclusion criteria (12 listed)
- Irregular heart beats,
- cardiac arrhythmia,
- moderate or severe valvular heart disease,
- preoperative left ventriular ejection fraction less than 40%,
- moderate t severe obstructive 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 |
|---|---|---|
| Augmented ventilationWhen the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration. | Other | Augmented ventilation with fluid loading |
| Fluid loadingAlso: Balanced crystalloid infusionWe record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid | Other | Augmented ventilation with fluid loading |
Primary outcome
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness
Time frame: within 2 min from augmented ventilation
Augmented ventilation (12ml/kg) will be performed when the participant's PPV is within grey zone (9-13%). PPV value will be collected automatically by Intelivue philips patient monitor. Percentage changes in stroke volume index by EV1000 according to fluid loading were used as principal indicators of fluid responsiveness. Patients were classified as responders or non-responders when increases in SVI were ≥ 10% or <10% after volume loading (crystalloid iv 6ml/kg). To test the abilities of augmented PPV to predict fluid responsiveness, areas under the receiver operating characteristics (ROC) curves of the responders [area under the curve (AUC) = 0.5: no better than chance, no prediction possible; AUC = 1.0: best possible prediction] will be calculated.
1 secondary outcome
Conventional baseline PPV to predict fluid responsiveness
Time frame: when patients PPV in grey zone, before augmented ventilation
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 4 Mar 2016.
- Derived from this study: PubMed 28974059Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.
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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.
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 Gynecologic Neoplasms and Abdominal Neoplasms, run by Samsung Medical Center 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 12 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 4 Mar 2016. 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?
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness (time frame: within 2 min from augmented ventilation). 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 NCT02653469, which also lists 1 linked publication.
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 4 Mar 2016; AzTrials last refreshed its copy on 29 Oct 2026.