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OpenTrials
Completed

NCT Number: NCT02535013

Intraoperative Lung Ultrasound in Pediatric Patients

Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.

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Key information

Conditions

Ultrasonography Cardiac Surgical Procedures Lung Pediatrics Perioperative Period

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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

  • Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia

Exclusion criteria

  • History of surgery on the lungs
  • Cyanotic congenital heart disease
  • Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
  • Considered inappropriate by the investigator

Treatment and study plan

Lung ultrasound

Device

Lung ultrasound with appropriate interventions depending on the ultrasound finding

Primary outcomes

  1. Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)

    Time frame: from the induction of general anesthesia until the end of the surgery, up to 24 hours

  2. Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)

    Time frame: within the first day after surgery

  3. Postoperative incidence of respiratory complications

    Time frame: within the first day after surgery

Secondary outcomes

  1. Intraoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis

    Time frame: from the induction of general anesthesia until the end of the surgery, up to 24 hours

  2. Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis

    Time frame: within the first day after surgery

  3. Initial SpO2 on arriving at pediatric intensive care unit

    Time frame: from the end of the surgery until postoperative 1 hour

  4. Days needed to wean from mechanical ventilation

    Time frame: up to 1 month

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery

Acronym: LUS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2015
Registry last updated
Dec 26, 2016

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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