Fraction of Inspired Oxygen and Atelectasis in Children

August 23, 2017 updated by: Jin-Tae Kim, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative atelectasis
Time Frame: within the first day after the surgery
within the first day after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of atelectasis after endotracheal intubation
Time Frame: from the moment of endotracheal intubation until the end of surgery, up to 4 hours
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)
Time Frame: from the induction of general anesthesia until the end of the surgery, up to 4 hours
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)
Time Frame: within the first day after the surgery
within the first day after the surgery
Postoperative incidence of fever (≥37.5℃)
Time Frame: within the first day after the surgery
within the first day after the surgery
Postoperative incidence of respiratory complications
Time Frame: within the first day after the surgery
within the first day after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 14, 2016

First Submitted That Met QC Criteria

August 14, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1607-150-778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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