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Completed

NCT Number: NCT02870842

Fraction of Inspired Oxygen and Atelectasis in Children

Investigators hypothesized that maintaining low fraction of inspired oxygen would be beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children undergoing general anesthesia.

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Key information

Conditions

Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases

Age range

Up to 7 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

  • Expected operation time between 1 to 3 hours under general anesthesia
  • Mechanically ventilated after endotracheal intubation

Exclusion criteria

  • Cardiac, thoracic, abdominal surgery
  • History of surgery on the lungs
  • Laparoscopic surgery
  • 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 on both hemithorax in supine position

Respiratory management

Other

Appropriate respiratory managements depending on the lung ultrasound findings

Primary outcomes

  1. Incidence of postoperative atelectasis

    Time frame: within the first day after the surgery

Secondary outcomes

  1. Incidence of atelectasis after endotracheal intubation

    Time frame: from the moment of endotracheal intubation until the end of surgery, up to 4 hours

  2. 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 4 hours

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

    Time frame: within the first day after the surgery

  4. Postoperative incidence of fever (≥37.5℃)

    Time frame: within the first day after the surgery

  5. Postoperative incidence of respiratory complications

    Time frame: within the first day after the surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Aug 24, 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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