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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
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Study Description
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Brief Summary:

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
Laparoscopic Surgery

Study Design
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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
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Pleth variability index(PVI) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes. ]

Secondary Outcome Measures :
  1. Systolic pressure variation(SPV) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes. ]
  2. Pulse pressure variation(PPV) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes ]
  3. Pulse oximeter plethysmographic waveform amplitude (△POP) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes ]

Eligibility Criteria
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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
Study Population
Pediatric patients undergoing laparoscopic surgery
Criteria

Inclusion Criteria:

  • Pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

  • known arrhythmia
  • known lung disease
  • known cardiac dysfunction (Ejection fraction less than 30%)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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