Pulmonary AtelectasisNCT02584023
Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants
A study testing Lung ultrasound in people with Pulmonary Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- Lung ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jan 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minor surgery less than 2 hours under general anesthesia
- Mechanically ventilated after endotracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants
Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.
- Conditions
- Pulmonary Atelectasis
- Being tested
- Lung ultrasound
- Keywords
- ultrasonography, infant, perioperative period, general anesthesia
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDevice
Lung ultrasound on both hemithorax in supine position
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery. Receives: Device: Lung ultrasound |
| Alveolar recruitment | Active comparator | Perform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment. Receives: Device: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative incidence of pulmonary atelectasis
Measured: within the first day after the surgery
Secondary outcomes (3)
Intraoperative incidence of pulmonary atelectasis after endotracheal intubation
Measured: from the moment of endotracheal intubation until the end of surgery, up to 6 hours
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Measured: from the induction of general anesthesia until the end of the surgery, up to 6 hours
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Measured: within the first day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584023
- Sponsor's protocol ID
- H-1509-063-703
- Status last verified
- Jun 2016
- First submitted
- 20 Oct 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.
PubMed 17238882Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.
PubMed 12821566Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
PubMed 12502973Ashton-Cleary DT. Is thoracic ultrasound a viable alternative to conventional imaging in the critical care setting? Br J Anaesth. 2013 Aug;111(2):152-60. doi: 10.1093/bja/aet076. Epub 2013 Apr 12.
PubMed 23585400Kiley S, Cassara C, Fahy BG. Lung ultrasound in the intensive care unit. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):196-203. doi: 10.1053/j.jvca.2014.10.017. No abstract available.
PubMed 25620145Acosta 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.
PubMed 24662376
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants
- ClinicalTrials.gov ID
- NCT02584023
- Acronym / sponsor ID
- H-1509-063-703
- Conditions
- Pulmonary Atelectasis
- Keywords
- ultrasonography, infant, perioperative period, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Oct 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.
Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Lung ultrasoundNo intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery. |
| Alveolar recruitment | Active comparator | Device: Lung ultrasoundPerform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Minor surgery less than 2 hours under general anesthesia
- Mechanically ventilated after endotracheal intubation
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Lung ultrasoundLung ultrasound on both hemithorax in supine position | Device | Alveolar recruitment, Control |
Primary outcome
Postoperative incidence of pulmonary atelectasis
Time frame: within the first day after the surgery
3 secondary outcomes
Intraoperative incidence of pulmonary atelectasis after endotracheal intubation
Time frame: from the moment of endotracheal intubation until the end of surgery, up to 6 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 6 hours
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Time frame: within the first day after the surgery
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 22 Jun 2016.
- Background: PubMed 17238882Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.
- Background: PubMed 12821566Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.
- Background: PubMed 12502973Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
- Background: PubMed 23585400Ashton-Cleary DT. Is thoracic ultrasound a viable alternative to conventional imaging in the critical care setting? Br J Anaesth. 2013 Aug;111(2):152-60. doi: 10.1093/bja/aet076. Epub 2013 Apr 12.
- Background: PubMed 25620145Kiley S, Cassara C, Fahy BG. Lung ultrasound in the intensive care unit. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):196-203. doi: 10.1053/j.jvca.2014.10.017. No abstract available.
- Background: PubMed 24662376Acosta 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.
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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.
Jin-Tae Kim principal investigator
Seoul National University 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 Lung ultrasound in people with Pulmonary Atelectasis, run by Seoul National University 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 2 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 22 Jun 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. Some participants in this study may receive a placebo. 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?
Postoperative incidence of pulmonary atelectasis (time frame: within the first day after the surgery). 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 NCT02584023, which also lists 6 linked publications.
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 22 Jun 2016.