Atelectasis, PostoperativeNCT02499536
Relationship Between Atelectasis on Ultrasound and PaO2/FiO2
A study testing ultrasound in people with Atelectasis, Postoperative, run by Severance Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding on intraoperative lung ultrasound. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Atelectasis, Postoperative
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The patients with abnormal chest x-ray finding,
- pregnancy,
- arrhythmia,
- ischemic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Intraoperative Atelectasis Findings on Transthoracic Lung Ultrasound and PaO2/FiO2
The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding on intraoperative lung ultrasound.
Read the 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.
- Conditions
- Atelectasis, Postoperative
- Being tested
- ultrasound
- Keywords
- Atelectasis, Postoperative, Lung ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | After general anesthesia development of the atelectasis will be investigated by the lung ultrasound Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Change in PaO2/FiO2
Arterial blood sampling to find out whether their is a change in PaO2/FiO2 before and after surgery.
Measured: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Secondary outcomes (1)
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
Measured: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atelectasis, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Koh, Jae Chul, MD, Severance Hospital
- Investigators
- Ji young Kim, MD, PhD, Study director, Department of anesthesiology and pain medicine, Gangnam Severance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499536
- Sponsor's protocol ID
- 2015-0189-002
- Status last verified
- Apr 2016
- First submitted
- 10 Jul 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19225063
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Intraoperative Atelectasis Findings on Transthoracic Lung Ultrasound and PaO2/FiO2
- ClinicalTrials.gov ID
- NCT02499536
- Acronym / sponsor ID
- 2015-0189-002
- Conditions
- Atelectasis, Postoperative
- Keywords
- Atelectasis, Postoperative, Lung ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Device: ultrasoundAfter general anesthesia development of the atelectasis will be investigated by the lung ultrasound |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- The patients with abnormal chest x-ray finding,
- pregnancy,
- arrhythmia,
- ischemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundJuxtapleural 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. | Device | Study participants |
Primary outcome
Intraoperative lung ultrasound for atelectasis
Time frame: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
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
Time frame: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Arterial blood sampling to find out whether their is a change in PaO2/FiO2 before and after surgery.
1 secondary outcome
Airway pressure change
Time frame: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Background: PubMed 19225063Lichtenstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji young Kim, MD, PhD study director
Department of anesthesiology and pain medicine, Gangnam Severance hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Atelectasis, Postoperative, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative lung ultrasound for atelectasis (time frame: Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.