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Active, not recruiting Observational

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

NCT06196125 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2023-11-30
Last updated
2025-05-20

Condition(s) studied

Trauma ChestMechanical Ventilation

Investigational drug(s) / intervention(s)

Four body positions

Four body positions: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age of ≥ 18 years 2. Traumatic lung injury with at least 2 rib fractures with or without chest tube and requiring mechanical ventilation 3. On any mode of ventilation including partially assisted breathing mode 4. With an "activity as tolerated (AAT) order" with or without C-collar Exclusion Criteria: 1. Refusal of consent 2. Palliative or end of life condition 3. Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement 4. Vasopressor: greater than 0.4 mcg/kg/min of norepinephrine infusion

Primary outcome measure(s)

  • Difference in ventilation distribution (%) — 4.75 hours
    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).
  • Difference in end expiratory lung volume (mL) — 4.75 hours
    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).

Trial sites (1)

FacilityCityRegionStatus
St. Michael's Hospital Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06196125 on ClinicalTrials.gov ↗ ← All trials in Canada