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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03467711
Enrollment
42
Registered
2018-03-16
Start date
2018-03-16
Completion date
2018-05-01
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Surgery

Brief 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.

Interventions

transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge)

give 6ml/kg (predicted body weight) volulyte for 10min

Sponsors

Hallym University Kangnam Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult patients who performed robot assisted laparoscopic surgery under Trendelenburg position

Exclusion criteria

* preoperative arrhythmia * Severe bradycardia * Moderate to severe valvular disease * left ventricular ejection fraction \< 50% * Poorly controlled hypertension (systolic BP \> 160 mmHg) * Patients with renal insufficiency (creatinine \> 1.5 mg/dL) * Moderate to severe liver disease * BMI \>.30 or \< 15 kg/ m2 * preexisting pulmonary disease * FEV1 \< 60% of predicted value * contraindications to oesophageal Doppler (OED) monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)

Design outcomes

Primary

MeasureTime frameDescription
PPV83min after tidal volume challengeaugmented pulse pressure variation using a temporary increase in VT
SVV83min after tidal volume challengeaugmented stroke volume variation using a temporary increase in VT

Secondary

MeasureTime frameDescription
PPV6Before fluid expansionThe value of pulse pressure variation when protective ventilation applied
SVV6Before fluid expansionThe value of stroke volume variation when protective ventilation applied
ΔPPV6-83min after tidal volume challengeThe changes in pulse pressure variation obtained by transiently increasing tidal volume
SVV_fb5min after fluid expansionThe change in SVV after giving the fluid bolus
PPV_fb5min after fluid expansionThe change in PPV after giving the fluid expansion
ΔSVV6-83min after tidal volume challengeThe changes in stroke volume variation obtained by transiently increasing tidal volume

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026