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NCT Number: NCT06386120

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

PEEP setting strategy

Other

The attending physician selects different PEEP setting strategies

Primary outcomes

  1. ventilation blood flow ratio

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

    ventilation blood flow ratio of lung

Secondary outcomes

  1. oxygenation index

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

    oxygenation index of participant

  2. 28-day mortality

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

    28-day mortality

  3. Mechanical ventilation-free from day 1 to 28

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

    Mechanical ventilation-free from day 1 to 28

  4. Length of ICU stay

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

    Length of ICU stay

  5. Length of hospital stay

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

    Length of hospital stay

  6. The rate of successful weaning

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

    the absence of the requirement for ventilatory support, without reintubation, a cardiac arrest event, or mortality within 48h after extubating or withdrawal

Study contacts

Contact information is provided by the study sponsor or research team.

Shu Li, doctor

CONTACT

[email protected]

+86 010 88324480

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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