RecruitmentNCT04008758
Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
A study testing Ultrasound in people with Recruitment and Trauma, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recruitment, Trauma
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 31 Dec 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who need surgery under general anesthesia due to trauma
- The position of the surgery is supine
Who cannot join
- Who has been ventilator care before the surgery
- Thoracic surgery
- Who had cardiopulmonary resuscitation
- Who has acute respiratory distress syndrome
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
In Kyong Yi, MD, +82-10-3012-6972, lyrin01@gmail.com
About this study
Official title: Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.
Read the detailed description
In trauma patients, the incidence of pulmonary contusion is 17-75%. Pulmonary contusioin leads to atelectasis, lung consolidatioin. Finally it could results acute respiratory distress syndrome.
Lung ultrasound is non-invasive and available in anytime even during surgery. Previous studies showed recruitment maneuver using ultrasound improved postoperative oxygenation in pediatric cardiac surgery. In adults, recruitment maneuver not using ultrasound improved oxygenation after cardiopulmonary bypass. There is no study in adult trauma population.
The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.
- Conditions
- Recruitment, Trauma
- Being tested
- Ultrasound
- Keywords
- recruitment, ultrasound, trauma, pulmonary contusion
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Evaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver
| Study group | Role | What they receive |
|---|---|---|
| sono group | Experimental | Evaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary Receives: Diagnostic Test: Ultrasound |
| control group | No intervention | If participants need recruitment maneuver (decreasing saturation, peak airway pressure > 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery
= P /F ratio; Smaller value respresents poor outcome Using arterial blood gas analysis the difference between baseline (immediate after intubation) and end of surgery
: If P/F ratio difference is improved compared to baseline, it means recruitment maneuver is effective
Measured: 2 hours
Secondary outcomes (1)
Lung ultrasound score
Using lung ultrasound, evaluate lung condition in both group at end of surgery Scoring using "lung ultrasound scoring" Scoring range: 0, normal; 1, small loss of aeration; 2, moderate loss of aeration; 4, severe loss of aeration
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective trial 1. st group is sono group using lung ultrasound 2. nd group is control group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008758
- Sponsor's protocol ID
- AJIRB-MED-OBS-19-119
- Status last verified
- Mar 2023
- First submitted
- 2 Jul 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
- ClinicalTrials.gov ID
- NCT04008758
- Acronym / sponsor ID
- AJIRB-MED-OBS-19-119
- Conditions
- Recruitment, Trauma
- Keywords
- recruitment, ultrasound, trauma, pulmonary contusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jul 2019 (actual)
- 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.
In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.
Detailed description
In trauma patients, the incidence of pulmonary contusion is 17-75%. Pulmonary contusioin leads to atelectasis, lung consolidatioin. Finally it could results acute respiratory distress syndrome.
Lung ultrasound is non-invasive and available in anytime even during surgery. Previous studies showed recruitment maneuver using ultrasound improved postoperative oxygenation in pediatric cardiac surgery. In adults, recruitment maneuver not using ultrasound improved oxygenation after cardiopulmonary bypass. There is no study in adult trauma population.
The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective trial 1. st group is sono group using lung ultrasound 2. nd group is control group
| Arm | Type | Receives |
|---|---|---|
| sono group | Experimental | Diagnostic Test: UltrasoundEvaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary |
| control group | No intervention | –If participants need recruitment maneuver (decreasing saturation, peak airway pressure > 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Who need surgery under general anesthesia due to trauma
- The position of the surgery is supine
Key exclusion criteria (4 listed)
- Who has been ventilator care before the surgery
- Thoracic surgery
- Who had cardiopulmonary resuscitation
- Who has acute respiratory distress syndrome
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 |
|---|---|---|
| UltrasoundEvaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver | Diagnostic test | sono group |
Primary outcome
arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery
Time frame: 2 hours
= P /F ratio; Smaller value respresents poor outcome Using arterial blood gas analysis the difference between baseline (immediate after intubation) and end of surgery : If P/F ratio difference is improved compared to baseline, it means recruitment maneuver is effective
1 secondary outcome
Lung ultrasound score
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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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.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
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 Recruitment and Trauma, run by Ajou University School of Medicine 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In Kyong Yi, MD (+82-219-7522, lyrin01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2023.