Clinical Trials Directory

Trials / Completed

CompletedNCT03467711

The Use of Tidal Volume Challenge of Dynamic Parameters During Laparoscopic Surgery

The Use of Tidal Volume Challenge to Improve the Reliability of Dynamic Parameters (Pulse Pressure Variation and Stroke Volume Variation) During Pneumoperitoneum and Laparoscopic Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Hallym University Kangnam Sacred Heart Hospital · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Accepted

Summary

Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important. Many studies have reported that less invasive dynamic indices such as pulse pressure variation (PPV) and stroke volume variation (SVV), which are derived from the arterial pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system. Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. It has been clearly shown that the values of dynamic parameters are significantly correlated with the magnitude of VT. Min et al. reported that augmentation of PPV and SVV via a temporary increase in VT from 8 to 12 ml/kg improved their predictive power in the inconclusive zone with respect to fluid responsiveness (PPV values of 9% and 13%, respectively). Another recent study reported that on increasing VT from 6 to 8 ml/kg, augmented PPV and SVV, as well as their absolute changes, predicted fluid responsiveness with high sensitivity and specificity, even in critically ill patients receiving low VT. Therefore, the aim of the current study was to investigate whether increasing VT from 6 to 8 ml/kg would improve the predictive power of PPV and SVV in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. We also assessed the ability of absolute changes in PPV and SVV values induced by a temporary increase in VT from 6 to 8 ml/kg to predict fluid responsiveness.

Conditions

Interventions

TypeNameDescription
OTHERtidal volume challengetransiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge)
OTHERvolume expansiongive 6ml/kg (predicted body weight) volulyte for 10min

Timeline

Start date
2018-03-16
Primary completion
2018-03-16
Completion
2018-05-01
First posted
2018-03-16
Last updated
2019-02-21

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03467711. Inclusion in this directory is not an endorsement.