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

NCT06386120 | Not Yet Recruiting

• 1 other identifier: 2024-z033
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Contusion

Keywords

chest contusion; lung contusion; electrical impedance tomography; pulmonary perfusion

Outcome Measures

Primary Outcomes (1)

• ventilation blood flow ratio

  ventilation blood flow ratio of lung

  through study completion, an average of 1 year

Secondary Outcomes (6)

• oxygenation index

  through study completion, an average of 1 year

• 28-day mortality

  through study completion, an average of 1 year

• Mechanical ventilation-free from day 1 to 28

  through study completion, an average of 1 year

• Length of ICU stay

  through study completion, an average of 1 year

• Length of hospital stay

  through study completion, an average of 1 year

Study Arms (2)

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

PEEP setting strategy OTHER

The attending physician selects different PEEP setting strategies

EIT-PEEP group; Table-PEEP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will be selected from a tertiary hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Officials

• Shu Li, doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Li, doctor

CONTACT

+86 010 88324480; lishu2401@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.