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Relationship Between Atelectasis on Ultrasound and PaO2/FiO2

Primary Purpose

Atelectasis, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atelectasis, Postoperative focused on measuring Atelectasis, Postoperative, Lung ultrasound

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 20~65
  • with ASA class 1 or 2
  • who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation

Exclusion Criteria:

  • The patients with abnormal chest x-ray finding,
  • pregnancy,
  • arrhythmia,
  • ischemic heart disease

Sites / Locations

  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study participants

Arm Description

After general anesthesia development of the atelectasis will be investigated by the lung ultrasound

Outcomes

Primary Outcome Measures

Intraoperative lung ultrasound for atelectasis
Lung ultrasound examination for atelectasis findings (eg. whether there is a loss of A line or presence of B lines before and after surgery)
Change in PaO2/FiO2
Arterial blood sampling to find out whether their is a change in PaO2/FiO2 before and after surgery.

Secondary Outcome Measures

Airway pressure change
To find out if there is any difference between preoperative and postoperative airway pressures(peak and plateau pressure), monitored by ventilator used during general anesthesia in mmHg

Full Information

First Posted
July 10, 2015
Last Updated
April 25, 2016
Sponsor
Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02499536
Brief Title
Relationship Between Atelectasis on Ultrasound and PaO2/FiO2
Official Title
Relationship Between Intraoperative Atelectasis Findings on Transthoracic Lung Ultrasound and PaO2/FiO2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding on intraoperative lung ultrasound.
Detailed Description
Patients aged 20~65 with ASA class (American Society of Anesthesiologists physical status classification) 1 or 2 who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation will participate in this study. The patients with abnormal chest x-ray finding, pregnancy, arrhythmia, ischemic heart disease will be excluded from this study as well as the patients who are scheduled to undergo lung or heart surgery. After 5 minutes preoxygenation, patients will be monitored with pulse oxymetry, noninvasive blood pressure. General anesthesia will be proceeded with typical method and endotracheal intubation and arterial cannulation will be proceeded. After ventilator adjustment (tidal volume as 8 times of the patient's ideal body weight), airway pressures(peak and plateau) will be recorded. Subsequently, arterial blood sampling will be proceeded while examination of the atelectasis findings on lung ultrasound before surgery. Lung ultrasound examination will be proceeded on 6 sections of patient's basal segments of the lung, including anterior, lateral, posterior segment. Juxtapleural consolidation, loss of A lines, presence of B lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded. Same ultrasound examination and arterial blood sampling will be followed after surgery ends. The results of PaO2/FiO2 on arterial blood samplings will be compared with findings on lung ultrasound before and after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative
Keywords
Atelectasis, Postoperative, Lung ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study participants
Arm Type
Experimental
Arm Description
After general anesthesia development of the atelectasis will be investigated by the lung ultrasound
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
Juxtapleural consolidation, loss of A lines, presence of B lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded.
Primary Outcome Measure Information:
Title
Intraoperative lung ultrasound for atelectasis
Description
Lung ultrasound examination for atelectasis findings (eg. whether there is a loss of A line or presence of B lines before and after surgery)
Time Frame
Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Title
Change in PaO2/FiO2
Description
Arterial blood sampling to find out whether their is a change in PaO2/FiO2 before and after surgery.
Time Frame
Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Secondary Outcome Measure Information:
Title
Airway pressure change
Description
To find out if there is any difference between preoperative and postoperative airway pressures(peak and plateau pressure), monitored by ventilator used during general anesthesia in mmHg
Time Frame
Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20~65 with ASA class 1 or 2 who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation Exclusion Criteria: The patients with abnormal chest x-ray finding, pregnancy, arrhythmia, ischemic heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji young Kim, MD, PhD
Organizational Affiliation
Department of anesthesiology and pain medicine, Gangnam Severance hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
135-720
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19225063
Citation
Lichtenstein D, Meziere G, Seitz J. The dynamic air bronchogram. A lung ultrasound sign of alveolar consolidation ruling out atelectasis. Chest. 2009 Jun;135(6):1421-1425. doi: 10.1378/chest.08-2281. Epub 2009 Feb 18.
Results Reference
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Relationship Between Atelectasis on Ultrasound and PaO2/FiO2

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