Relationship Between Atelectasis on Ultrasound and PaO2/FiO2

Atelectasis, Postoperative Clinical Trial

Official title:

Relationship Between Intraoperative Atelectasis Findings on Transthoracic Lung Ultrasound and PaO2/FiO2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499536
• Other study ID #: 2015-0189-002
• Status: Completed
• Phase: N/A
• First received: July 10, 2015
• Last updated: April 25, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding on intraoperative lung ultrasound.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atelectasis, Postoperative
• Pulmonary Atelectasis

Intervention

Device:
• ultrasound
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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Lichtenstein D, Mezière G, Seitz J. The dynamic air bronchogram. A lung ultrasound sign of alveolar consolidation ruling out atelectasis. Chest. 2009 Jun;135(6):1421-5. doi: 10.1378/chest.08-2281. Epub 2009 Feb 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)	No
Primary	Change in PaO2/FiO2	Arterial blood sampling to find out whether their is a change in PaO2/FiO2 before and after surgery.	Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)	No
Secondary	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	Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)	No