- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467711
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Kangnam Sacred Heart Hospital, Hallym University College of Medicine
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PPV8
Time Frame: 3min after tidal volume challenge
|
augmented pulse pressure variation using a temporary increase in VT
|
3min after tidal volume challenge
|
|
SVV8
Time Frame: 3min after tidal volume challenge
|
augmented stroke volume variation using a temporary increase in VT
|
3min after tidal volume challenge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ΔPPV6-8
Time Frame: 3min after tidal volume challenge
|
The changes in pulse pressure variation obtained by transiently increasing tidal volume
|
3min after tidal volume challenge
|
|
ΔSVV6-8
Time Frame: 3min after tidal volume challenge
|
The changes in stroke volume variation obtained by transiently increasing tidal volume
|
3min after tidal volume challenge
|
|
PPV6
Time Frame: Before fluid expansion
|
The value of pulse pressure variation when protective ventilation applied
|
Before fluid expansion
|
|
SVV6
Time Frame: Before fluid expansion
|
The value of stroke volume variation when protective ventilation applied
|
Before fluid expansion
|
|
PPV_fb
Time Frame: 5min after fluid expansion
|
The change in PPV after giving the fluid expansion
|
5min after fluid expansion
|
|
SVV_fb
Time Frame: 5min after fluid expansion
|
The change in SVV after giving the fluid bolus
|
5min after fluid expansion
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-009-003-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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