Fraction of Inspired Oxygen and Atelectasis in Children

Not Applicable

Completed

• Conditions: Pulmonary Atelectasis
• Interventions: Device: Lung ultrasound; Other: Respiratory management

• Registration Number: NCT02870842
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-14
• Study First Submitted QC: 2016-08-14
• Study First Posted: 2016-08-17
• Study Start: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-23
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Lung ultrasound	Perform recruitment maneuver with fraction of inspired oxygen (FiO2) of 1.0 after intubation under lung ultrasound guidance and maintain FiO2 of 0.6 during the general anesthesia.
Low FiO2	Respiratory management	Perform recruitment maneuver with low FiO2 of 0.3 after intubation under lung ultrasound guidance and maintain FiO2 of 0.3 during the general anesthesia.
Control	Respiratory management	Perform recruitment maneuver with fraction of inspired oxygen (FiO2) of 1.0 after intubation under lung ultrasound guidance and maintain FiO2 of 0.6 during the general anesthesia.
Low FiO2	Lung ultrasound	Perform recruitment maneuver with low FiO2 of 0.3 after intubation under lung ultrasound guidance and maintain FiO2 of 0.3 during the general anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative atelectasis	within the first day after the surgery

Secondary Outcome Measures

Name	Time	Method
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 respiratory complications	within the first day after the surgery
Postoperative incidence of fever (≥37.5℃)	within the first day after the surgery
Incidence of atelectasis after endotracheal intubation	from the moment of endotracheal intubation until the end of 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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of