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Completed

NCT Number: NCT02536521

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

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).

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Key information

Conditions

Laparoscopic Surgery

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients undergoing laparoscopic surgery

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Pleth variability index(PVI)

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: Lapa-BP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2015
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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