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OpenTrials
Completed

NCT Number: NCT02653469

Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

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.

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Key information

Conditions

Gynecologic Neoplasms Abdominal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented ventilation

Other

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 Loading

Other

We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid

Other names: Balanced crystalloid infusion

Primary outcomes

  1. 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.

Secondary outcomes

  1. Conventional baseline PPV to predict fluid responsiveness

    Time frame: when patients PPV in grey zone, before augmented ventilation

    PPV value will be collected automatically by Intelivue philips patient monitor.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2016
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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