Fraction of Inspired Oxygen and Atelectasis in Children

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02870842

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Atelectasis	Device: Lung ultrasound Other: Respiratory management	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control 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.	Device: Lung ultrasound Lung ultrasound on both hemithorax in supine position Other: Respiratory management Appropriate respiratory managements depending on the lung ultrasound findings
Active Comparator: Low FiO2 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.	Device: Lung ultrasound Lung ultrasound on both hemithorax in supine position Other: Respiratory management Appropriate respiratory managements depending on the lung ultrasound findings

Arm

Intervention/Treatment

Placebo Comparator: Control

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.

Device: Lung ultrasound

Lung ultrasound on both hemithorax in supine position

Other: Respiratory management

Appropriate respiratory managements depending on the lung ultrasound findings

Active Comparator: Low FiO2

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.

Device: Lung ultrasound

Lung ultrasound on both hemithorax in supine position

Other: Respiratory management

Appropriate respiratory managements depending on the lung ultrasound findings

Outcome Measures

Primary Outcome Measures

Incidence of postoperative atelectasis [within the first day after the surgery]

Secondary Outcome Measures

Incidence of atelectasis after endotracheal intubation [from 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 complications [within the first day after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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