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NCT02536521 Clinical Trial

Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children

Laparoscopic Surgery Clinical Trial

— Lapa-BP  

Official title:
Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02536521
Other study ID # H-1507-039-686
Secondary ID
Status Completed
Phase N/A
First received August 24, 2015
Last updated June 14, 2017
Start date August 2015
Est. completion date May 2017

Study information
Verified date June 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Years
Eligibility Inclusion Criteria:

- Pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

- known arrhythmia

- known lung disease

- known cardiac dysfunction (Ejection fraction less than 30%)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pleth variability index(PVI) Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Secondary Systolic pressure variation(SPV) Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Secondary Pulse pressure variation(PPV) Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Secondary Pulse oximeter plethysmographic waveform amplitude (?POP) Outcome measure will be assessed before the CO2 desufflation for about 2minutes
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