NCT02536521

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

August 24, 2015

Last Update Submit

June 14, 2017

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Pleth variability index(PVI)

    Outcome measure will be assessed before the CO2 desufflation for about 2minutes.

Secondary Outcomes (3)

  • Systolic pressure variation(SPV)

    Outcome measure will be assessed before the CO2 desufflation for about 2minutes.

  • Pulse pressure variation(PPV)

    Outcome measure will be assessed before the CO2 desufflation for about 2minutes

  • Pulse oximeter plethysmographic waveform amplitude (△POP)

    Outcome measure will be assessed before the CO2 desufflation for about 2minutes

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing laparoscopic surgery

You may qualify if:

  • Pediatric patients undergoing laparoscopic surgery

You may not qualify if:

  • known arrhythmia
  • known lung disease
  • known cardiac dysfunction (Ejection fraction less than 30%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28981568DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 1, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 15, 2017

Record last verified: 2017-06

Locations

KR(1)