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Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children (Lapa-BP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 24, 2015
First Posted Date September 1, 2015
Last Update Posted Date June 15, 2017
Study Start Date August 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2015)
Pleth variability index(PVI) [ Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 27, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children
Official Title Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric patients undergoing laparoscopic surgery
Condition Laparoscopic Surgery
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Kim EH, Lee JH, Song IK, Ryu HG, Kim HS, Kim JT. Assessment of dynamic variables of fluid responsiveness to predict desufflation-induced hypotension during paediatric laparoscopic surgery. Br J Anaesth. 2017 Nov 1;119(5):956-963. doi: 10.1093/bja/aex172.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2017)
123
Original Estimated Enrollment
 (submitted: August 27, 2015)
36
Actual Study Completion Date May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

  • known arrhythmia
  • known lung disease
  • known cardiac dysfunction (Ejection fraction less than 30%)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 7 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02536521
Other Study ID Numbers H-1507-039-686
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date June 2017