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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Contusion
• Intervention / Treatment: Other: PEEP setting strategy

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Shu Li, doctor; Phone Number: +86 010 88324480; Email: lishu2401@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The cohort will be selected from a tertiary hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EIT-PEEP group; The PEEP titration guided by EIT, decided by the responsible attending physician	Other: PEEP setting strategy; The attending physician selects different PEEP setting strategies
Table-PEEP group; The PEEP setting with low FiO2-PEEP table, decided by the responsible attending physician	Other: PEEP setting strategy; The attending physician selects different PEEP setting strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilation blood flow ratio	ventilation blood flow ratio of lung	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation index	oxygenation index of participant	through study completion, an average of 1 year
28-day mortality	28-day mortality	through study completion, an average of 1 year
Mechanical ventilation-free from day 1 to 28	Mechanical ventilation-free from day 1 to 28	through study completion, an average of 1 year
Length of ICU stay	Length of ICU stay	through study completion, an average of 1 year
Length of hospital stay	Length of hospital stay	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Shu Li, doctor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: electrical impedance tomography; pulmonary perfusion; chest contusion; lung contusion
• Additional Relevant MeSH Terms: Wounds and Injuries; Contusions; Wounds, Nonpenetrating
• Other Study ID Numbers: 2024-z033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 1 year after publication
• IPD Sharing Access Criteria: The data used and/or analyzed during the current study are available from the Investigator on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No