Ventilation dIstribution and effeCt of posTural Lateralization On Traumatic Lung injuRY: a Physiological Study

NCT06196125 | Active Not Recruiting

• 1 other identifier: 23-231
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, physiological study. The study will enroll the traumatic lung injury patient who has at least 2 rib fractures requiring mechanical ventilation being on partially assisted breathing mode and on activity as tolerated (AAT) order with or without C-collar. Once being confirmed to meet the inclusion criteria, the research team will apply the EIT on the patient and start recording as well as perform lung ultrasound in the specific areas of interest in the selected time points of the study. The MV ventilator setting and some vital sign data will be also collected at selected time points of study. The EIT will continuously record from 5 minutes when patient is on supine position, then the investigators will turn patient using positioning wedge pillow to the sides with 30-minute EIT recording each side, lastly, the investigators will turn patient back to supine and continuously record for 30 minutes. The study will use the same protocol to perform in 3 different settings of mechanical ventilation (weaning process) i.) during partially assisted breathing, ii.) during high setting of spontaneous breathing and iii.) during low setting of spontaneous breathing.

Conditions

Trauma Chest; Mechanical Ventilation

Keywords

chest trauma; mechanical ventilation; positional changes

Outcome Measures

Primary Outcomes (2)

• Difference in ventilation distribution (%)

  The primary endpoint is to study the difference of ventilation distribution (%) during different stages of spontaneous breathing/partially assisted breathing among four different body positions (supine 1, lateral 1, lateral 2, supine 2).

  4.75 hours

• Difference in end expiratory lung volume (mL)

  The primary endpoint is to study end expiratory lung volume (EELV) in mL during different stages of spontaneous breathing/partially assisted breathing among four different body positions (supine 1, lateral 1, lateral 2, supine 2).

  4.75 hours

Secondary Outcomes (5)

• Patterns of ventilation distribution.

  95 minutes

• Correlation between ventilation distribution and lung aeration patterns.

  95 minutes

• Quantify Pendelluft in different body positions

  95 minutes

• Correlation of various traumatic lung injuries to ventilation distribution.

  95 minutes

• Correlation of duration of mechanical ventilation to lung aeration patterns.

  95 minutes

Study Arms (1)

Intubated mechanically ventilated patients with thoracic trauma.

Intubated and mechanically ventilated patients with thoracic trauma (with at least 2 rib fractures with or without chest tube), who are in spontaneous/ partially assisted breathing phase.

Other: Four body positions

Interventions

Four body positions OTHER

Physiological characteristics such as ventilation distribution and lung aeration patterns recorded by the electrical impedance tomography signals and ultrasound imaging will be measured when patients are in a initial supine position, then turned into a lateral positioning on each side then back in supine positioning.

Intubated mechanically ventilated patients with thoracic trauma.

Eligibility Criteria

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

Study Population

The patients will be selected from intensive care units.

You may qualify if:

• Age of ≥ 18 years
• Traumatic lung injury with at least 2 rib fractures with or without chest tube and requiring mechanical ventilation
• On any mode of ventilation including partially assisted breathing mode
• With an "activity as tolerated (AAT) order" with or without C-collar

You may not qualify if:

• Refusal of consent
• Palliative or end of life condition
• Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement
• Vasopressor: greater than 0.4 mcg/kg/min of norepinephrine infusion

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1T8, Canada

Location

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Laurent Brochard, MD

  St. Michael's hospital, Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 9, 2024
• Study Start: November 30, 2023
• Primary Completion: November 26, 2024
• Study Completion: November 30, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CA (1)