Lung ContusionNCT06386120
Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury
An observational study of Lung Contusion, run by Peking University People's Hospital.
Trial summary
The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Contusion
- What is being tested?
- PEEP setting strategy
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Jul 2026
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will be selected from a tertiary hospital
Who may be able to join
- Patients with severe chest contusion admitted to the intensive care unit (ICU);
- Abbreviated Injury Scale (AIS) ≥ 3 and/or Blunt Pulmonary Contusion 18 score (BPC18) ≥ 3;
- Age range from 18 to 90 years old;
- Mechanical ventilation;
- Stay in the ICU for less than 12 hours.
Who cannot join
- Perinatal women;
- Expected to be mechanically ventilated for less than 48 h;
- Expected duration of stay in the ICU is less than 24 hours;
- There are contraindications for the use of EIT (pacemaker implantation, local skin wounds after chest surgery, etc.);
- Accept extracorporeal membrane oxygenator;
- Mechanical ventilation>7 days;
- Confirmed ventilator-associated pneumonia;
- Pneumothorax without drainage or presence of subcutaneous emphysema.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Respiratory Function Monitoring of Patients With Chest Blunt Injury With Mechanical Ventilation
The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:
Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care.
Read the detailed description
Trauma is the leading cause of death among middle-aged and young people in China, with over 25% of patients dying from chest trauma. The incidence of pulmonary contusion in severe chest trauma is over 70%, and it is an important cause of respiratory failure and even death in patients. The occurrence of pulmonary contusion and respiratory failure in patients with chest contusion is a dynamic process, and Regional inhomogeneities of the damaged lung should be taken into consideration to develop improved ventilation strategies. Currently, there is no ideal monitoring method to evaluate the severity of injury, and guide the ventilation strategies. Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique. It measures regional lung ventilation and aeration distribution by means of changes in electrical potentials at the skin surface of the chest wall during breathing cycles, which has been proven to have good practicality in patients with non-invasive ARDS and pulmonary embolism. In this study, we aim to characterize the physiologic effects of positive end expiratory pressure (PEEP) on key mechanisms of regional lung protection, namely: recruitment, reduced atelectrauma, and improved ventilation-perfusion matching, by CT scan and EIT
- Conditions
- Lung Contusion
- Being tested
- PEEP setting strategy
- Keywords
- chest contusion, lung contusion, electrical impedance tomography, pulmonary perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP setting strategyOther
The attending physician selects different PEEP setting strategies
| Study group | Role | What they receive |
|---|---|---|
| EIT-PEEP group | The PEEP titration guided by EIT, decided by the responsible attending physician Receives: Other: PEEP setting strategy | |
| Table-PEEP group | The PEEP setting with low FiO2-PEEP table, decided by the responsible attending physician Receives: Other: PEEP setting strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilation blood flow ratio
ventilation blood flow ratio of lung
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
oxygenation index
oxygenation index of participant
Measured: through study completion, an average of 1 year
28-day mortality
28-day mortality
Measured: through study completion, an average of 1 year
Mechanical ventilation-free from day 1 to 28
Mechanical ventilation-free from day 1 to 28
Measured: through study completion, an average of 1 year
Length of ICU stay
Length of ICU stay
Measured: through study completion, an average of 1 year
Length of hospital stay
Length of hospital stay
Measured: through study completion, an average of 1 year
The rate of successful weaning
the absence of the requirement for ventilatory support, without reintubation, a cardiac arrest event, or mortality within 48h after extubating or withdrawal
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung ContusionStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shu, Peking University People's Hospital
- Investigators
- Shu Li, doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386120
- Sponsor's protocol ID
- 2024-z033
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Function Monitoring of Patients With Chest Blunt Injury With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06386120
- Acronym / sponsor ID
- 2024-z033
- Conditions
- Lung Contusion
- Keywords
- chest contusion, lung contusion, electrical impedance tomography, pulmonary perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Apr 2024 (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.
The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:
Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care.
Detailed description
Trauma is the leading cause of death among middle-aged and young people in China, with over 25% of patients dying from chest trauma. The incidence of pulmonary contusion in severe chest trauma is over 70%, and it is an important cause of respiratory failure and even death in patients. The occurrence of pulmonary contusion and respiratory failure in patients with chest contusion is a dynamic process, and Regional inhomogeneities of the damaged lung should be taken into consideration to develop improved ventilation strategies. Currently, there is no ideal monitoring method to evaluate the severity of injury, and guide the ventilation strategies. Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique. It measures regional lung ventilation and aeration distribution by means of changes in electrical potentials at the skin surface of the chest wall during breathing cycles, which has been proven to have good practicality in patients with non-invasive ARDS and pulmonary embolism. In this study, we aim to characterize the physiologic effects of positive end expiratory pressure (PEEP) on key mechanisms of regional lung protection, namely: recruitment, reduced atelectrauma, and improved ventilation-perfusion matching, by CT scan and EIT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-PEEP group | – | Other: PEEP setting strategyThe PEEP titration guided by EIT, decided by the responsible attending physician |
| Table-PEEP group | – | Other: PEEP setting strategyThe PEEP setting with low FiO2-PEEP table, decided by the responsible attending physician |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from a tertiary hospital
Key inclusion criteria (5 listed)
- Patients with severe chest contusion admitted to the intensive care unit (ICU);
- Abbreviated Injury Scale (AIS) ≥ 3 and/or Blunt Pulmonary Contusion 18 score (BPC18) ≥ 3;
- Age range from 18 to 90 years old;
- Mechanical ventilation;
- Stay in the ICU for less than 12 hours.
Key exclusion criteria (8 listed)
- Perinatal women;
- Expected to be mechanically ventilated for less than 48 h;
- Expected duration of stay in the ICU is less than 24 hours;
- There are contraindications for the use of EIT (pacemaker implantation, local skin wounds after chest surgery, etc.);
- Accept extracorporeal membrane oxygenator;
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 |
|---|---|---|
| PEEP setting strategyThe attending physician selects different PEEP setting strategies | Other | EIT-PEEP group, Table-PEEP group |
Primary outcome
ventilation blood flow ratio
Time frame: through study completion, an average of 1 year
ventilation blood flow ratio of lung
6 secondary outcomes
oxygenation index
Time frame: through study completion, an average of 1 year
28-day mortality
Time frame: through study completion, an average of 1 year
Mechanical ventilation-free from day 1 to 28
Time frame: through study completion, an average of 1 year
Length of ICU stay
Time frame: through study completion, an average of 1 year
Length of hospital stay
Time frame: through study completion, an average of 1 year
The rate of successful weaning
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Lung Contusion
Not yet recruitingObservational study
Combined Lung and Diaphragmatic Ultrasound to Predict Respiratory Failure in Blunt Chest Trauma
Blunt Chest Trauma, Respiratory Failure
Not yet recruitingObservational study
Non-Invasive Dynamic Monitoring-Guided Oscillation and Lung Expansion for Airway Clearance in Severe Blunt Chest Trauma: A Clinical Study
Blunt Chest Trauma
Recruiting
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
Lung Trauma, Lung Contusion
RecruitingObservational study
AI in the Identification of Lung Contusions Through Chest Radiological Examination in Blunt Thoracic Trauma
Lung Contusion
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.
Shu Li, doctor principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Contusion, run by Peking University People's Hospital.
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 5 inclusion and 8 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Shu Li, doctor (+86 010 88324480, lishu2401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilation blood flow ratio (time frame: through study completion, an average of 1 year). 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 26 Apr 2024.