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Fraction of Inspired Oxygen and Atelectasis in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02870842
Enrollment
86
Registered
2016-08-17
Start date
2016-09-30
Completion date
2017-01-31
Last updated
2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Atelectasis

Keywords

ultrasonography, child, perioperative period, general anesthesia, lung

Brief summary

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

Interventions

DEVICELung ultrasound

Lung ultrasound on both hemithorax in supine position

Appropriate respiratory managements depending on the lung ultrasound findings

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative atelectasiswithin the first day after the surgery

Secondary

MeasureTime frame
Incidence of atelectasis after endotracheal intubationfrom the moment of endotracheal intubation until the end of surgery, up to 4 hours
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)from the induction of general anesthesia until the end of the surgery, up to 4 hours
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)within the first day after the surgery
Postoperative incidence of fever (≥37.5℃)within the first day after the surgery
Postoperative incidence of respiratory complicationswithin the first day after the surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026