Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children (Lapa-BP)
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ClinicalTrials.gov Identifier: NCT02536521 |
Recruitment Status :
Completed
First Posted : September 1, 2015
Last Update Posted : June 15, 2017
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This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery.
The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).
Condition or disease |
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Laparoscopic Surgery |
Study Type : | Observational |
Actual Enrollment : | 123 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery |
Study Start Date : | August 2015 |
Actual Primary Completion Date : | May 2017 |
Actual Study Completion Date : | May 2017 |
Group/Cohort |
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Hemodynamically stable |
Hemodynamically unstable
Hemodynamically unstable patients are defined as those with a 20% decrease in systolic blood pressure according to the change of intraabdominal pressure.
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- Pleth variability index(PVI) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes. ]
- Systolic pressure variation(SPV) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes. ]
- Pulse pressure variation(PPV) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes ]
- Pulse oximeter plethysmographic waveform amplitude (△POP) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes ]

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Ages Eligible for Study: | up to 7 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Pediatric patients undergoing laparoscopic surgery
Exclusion Criteria:
- known arrhythmia
- known lung disease
- known cardiac dysfunction (Ejection fraction less than 30%)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536521
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Responsible Party: | Jin-Tae Kim, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT02536521 |
Other Study ID Numbers: |
H-1507-039-686 |
First Posted: | September 1, 2015 Key Record Dates |
Last Update Posted: | June 15, 2017 |
Last Verified: | June 2017 |