ClinicalTrials.gg
Not yet recruitingNCT06386120Updated Apr 26, 2024

Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury

An observational study in Lung Contusion, sponsored by Peking University People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Peking University People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Lung Contusion

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Keywords

  • chest contusion
  • lung contusion
  • electrical impedance tomography
  • pulmonary perfusion
03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 10 observational studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The cohort will be selected from a tertiary hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • EIT-PEEP group

    The PEEP titration guided by EIT, decided by the responsible attending physician

    Other: PEEP setting strategy

  • Table-PEEP group

    The PEEP setting with low FiO2-PEEP table, decided by the responsible attending physician

    Other: PEEP setting strategy

Interventions

  • OtherPEEP setting strategy

    The attending physician selects different PEEP setting strategies

06

What researchers measure

Primary outcomes

  1. ventilation blood flow ratio

    ventilation blood flow ratio of lung

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. oxygenation index

    oxygenation index of participant

    Time frame: through study completion, an average of 1 year

  2. 28-day mortality

    28-day mortality

    Time frame: through study completion, an average of 1 year

  3. Mechanical ventilation-free from day 1 to 28

    Mechanical ventilation-free from day 1 to 28

    Time frame: through study completion, an average of 1 year

  4. Length of ICU stay

    Length of ICU stay

    Time frame: through study completion, an average of 1 year

  5. Length of hospital stay

    Length of hospital stay

    Time frame: through study completion, an average of 1 year

  6. 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

    Time frame: through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: starting 1 year after publication

Access criteria: The data used and/or analyzed during the current study are available from the Investigator on reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for May 2026, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
Apr 26, 2024
StartEst.
May 2024
Primary completionEst.
May 2026
CompletionEst.
Jul 2026
Last update
Apr 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06386120
Responsible party
Li Shu (associate professor, Peking University People's Hospital) — Principal investigator
First posted
Apr 26, 2024
Start date
May 2024 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Apr 26, 2024

Study contacts

Shu Li, doctor
Contact
lishu2401@163.com
+86 010 88324480
Shu Li, doctor
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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