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Fraction of Inspired Oxygen and Atelectasis in Children

Primary Purpose

Pulmonary Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lung ultrasound
Respiratory management
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Atelectasis focused on measuring ultrasonography, child, perioperative period, general anesthesia, lung

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Low FiO2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of postoperative atelectasis

Secondary Outcome Measures

Incidence of atelectasis after endotracheal intubation
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Postoperative incidence of fever (≥37.5℃)
Postoperative incidence of respiratory complications

Full Information

First Posted
August 14, 2016
Last Updated
August 23, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02870842
Brief Title
Fraction of Inspired Oxygen and Atelectasis in Children
Official Title
Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
ultrasonography, child, perioperative period, general anesthesia, lung

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Low FiO2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lung ultrasound
Intervention Description
Lung ultrasound on both hemithorax in supine position
Intervention Type
Other
Intervention Name(s)
Respiratory management
Intervention Description
Appropriate respiratory managements depending on the lung ultrasound findings
Primary Outcome Measure Information:
Title
Incidence of postoperative atelectasis
Time Frame
within the first day after the surgery
Secondary Outcome Measure Information:
Title
Incidence of atelectasis after endotracheal intubation
Time Frame
from the moment of endotracheal intubation until the end of surgery, up to 4 hours
Title
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
Title
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Time Frame
within the first day after the surgery
Title
Postoperative incidence of fever (≥37.5℃)
Time Frame
within the first day after the surgery
Title
Postoperative incidence of respiratory complications
Time Frame
within the first day after the surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24662376
Citation
Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
Results Reference
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PubMed Identifier
21039356
Citation
Edmark L, Auner U, Enlund M, Ostberg E, Hedenstierna G. Oxygen concentration and characteristics of progressive atelectasis formation during anaesthesia. Acta Anaesthesiol Scand. 2011 Jan;55(1):75-81. doi: 10.1111/j.1399-6576.2010.02334.x. Epub 2010 Oct 29. Erratum In: Acta Anaesthesiol Scand. 2011 Jul;55(6):766.
Results Reference
background
PubMed Identifier
10519502
Citation
Akca O, Podolsky A, Eisenhuber E, Panzer O, Hetz H, Lampl K, Lackner FX, Wittmann K, Grabenwoeger F, Kurz A, Schultz AM, Negishi C, Sessler DI. Comparable postoperative pulmonary atelectasis in patients given 30% or 80% oxygen during and 2 hours after colon resection. Anesthesiology. 1999 Oct;91(4):991-8. doi: 10.1097/00000542-199910000-00019.
Results Reference
background
PubMed Identifier
26455945
Citation
Martin JB, Garbee D, Bonanno L. Effectiveness of positive end-expiratory pressure, decreased fraction of inspired oxygen and vital capacity recruitment maneuver in the prevention of pulmonary atelectasis in patients undergoing general anesthesia: a systematic review. JBI Database System Rev Implement Rep. 2015 Sep 16;13(8):211-49. doi: 10.11124/jbisrir-2015-1410.
Results Reference
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Fraction of Inspired Oxygen and Atelectasis in Children

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