CompletedNot Applicable

Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

South Korea38 participantsStarted 2015-09

Plain-language 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%. 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.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients undergoing elective open laparotomy surgery. Exclusion Criteria: * 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, * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness

Timeframe: within 2 min from augmented ventilation

Trial details

NCT IDNCT02653469

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-02

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