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Completed

NCT Number: NCT03467711

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

tidal volume challenge

Other

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

volume expansion

Other

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

Primary outcomes

  1. PPV8

    Time frame: 3min after tidal volume challenge

    augmented pulse pressure variation using a temporary increase in VT

  2. SVV8

    Time frame: 3min after tidal volume challenge

    augmented stroke volume variation using a temporary increase in VT

Secondary outcomes

  1. ΔPPV6-8

    Time frame: 3min after tidal volume challenge

    The changes in pulse pressure variation obtained by transiently increasing tidal volume

  2. ΔSVV6-8

    Time frame: 3min after tidal volume challenge

    The changes in stroke volume variation obtained by transiently increasing tidal volume

  3. PPV6

    Time frame: Before fluid expansion

    The value of pulse pressure variation when protective ventilation applied

  4. SVV6

    Time frame: Before fluid expansion

    The value of stroke volume variation when protective ventilation applied

  5. PPV_fb

    Time frame: 5min after fluid expansion

    The change in PPV after giving the fluid expansion

  6. SVV_fb

    Time frame: 5min after fluid expansion

    The change in SVV after giving the fluid bolus

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2018
Registry last updated
Feb 21, 2019

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

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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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