Trauma ChestVICTORYNCT06196125
Ventilation dIstribution and effeCt of posTural Lateralization On Traumatic Lung injuRY: a Physiological Study
An observational study of Trauma Chest and Mechanical Ventilation, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Chest, Mechanical Ventilation
- What is being tested?
- Four body positions
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be selected from intensive care units.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study will be conducted while the patient is partially assisted on a breathing machine and have been clinically indicated to mobilize as tolerated while in the weaning process in the ICU.
The investigators will use EIT to visualize where air goes in the patient's lungs and lung ultrasonography to visualize lung inflation in specific areas. EIT is a measurement often used in the ICU since it allows easy visualization and is a non-invasive technique. The sensors measure electrical current changes during inspiration and expiration and will not cause any pain or radiation concerns. The EIT belt (3-cm diameter) will be placed around the chest without causing adverse event/discomfort/pain to the injured thorax area and recording will occur for 5 minutes during the first supine position, then 30 minutes for each side of left and right lateral position using the 30 Degree wedge pillow to support. The pillow is routinely applied to every ICU patient when eligible to be positioned on their side. As routine practice, patients are turned on each side every 2 hours to prevent pressure sores. Lastly, the investigators will do a final 30-minute recording when the patient is turned back onto their back. The duration of study will be approximately 95 minutes per session, which includes placing the patient in the four positions (on the back, the left side, the right side and returning to the back). The investigators will perform the same protocol at three different times when they are at different stages of weaning off the breathing machine: i) during partially assisted breathing, ii.) during a high setting of spontaneous breathing and iii.) during low setting of spontaneous breathing). These 3 breathing machine's settings indicate the patient is on the pathway of weaning off the breathing machine. The total study hours will be 4.75 hours (3 sessions) and each breathing machine's setting will be adjusted by clinical team over time. The investigators will proceed with the measurements only with agreement from the clinical team. The investigators will analyze the data collected offline with a dedicated software afterwards.
This study may require arterial blood gas analysis at baseline and after the procedure, only if there is an arterial line in place. The information from the sample provides the investigator the status of participant's breathing and breathing machine settings. It allows for any appropriate adjustments to the breathing machine. After these study procedures are completed, data will also be collected from the participant's chart and combined with relevant information from the breathing machine settings and vital functions at each stage of position changes. Confidentiality will be maintained throughout the entire study.
- Conditions
- Trauma Chest, Mechanical Ventilation
- Being tested
- Four body positions
- Keywords
- chest trauma, mechanical ventilation, positional changes
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four body positionsOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Four body positions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 4.75 hours
Secondary outcomes (5)
Patterns of ventilation distribution.
To study the patterns of ventilation distribution and end expiratory lung volume during different stages of spontaneous breathing/partially assisted breathing on each position over period of time.
Measured: 95 minutes
Correlation between ventilation distribution and lung aeration patterns.
Physiological characteristics: ventilation distribution recorded by electrical impedance tomography and ultrasound guidance during body position changes, correlation with body position changes over period of time, correlation with details of traumatic lung injury and correlation with mechanical ventilation days and Intensive care unit length of stay.
Measured: 95 minutes
Quantify Pendelluft in different body positions
We would like to use electrical impedance tomography - a non-invasive and informative tool to study the ventilation distribution and the Pendelluft during spontaneous breathing or assisted ventilation during body position changes in traumatic lung injury patient.
Measured: 95 minutes
Correlation of various traumatic lung injuries to ventilation distribution.
To identify the correlation among details of traumatic lung injury (type, location, number of rib fracture, side of rib fracture) with ventilation distribution, lung aeration patterns and effect of positional changes through ultrasound and electrical impedance tomography data.
Measured: 95 minutes
Correlation of duration of mechanical ventilation to lung aeration patterns.
To identify the correlation of the previous duration of mechanical ventilation (from date of initiating mechanical ventilation to enrolment), with the result of ventilation distribution and lung aeration patterns from the effect of positional changes.
Measured: 95 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start30 Nov 2023
- Primary completion26 Nov 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Brochard, MD, Principal investigator, St. Michael's hospital, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196125
- Sponsor's protocol ID
- 23-231
- Acronym
- VICTORY
- Status last verified
- May 2025
- First submitted
- 23 Dec 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Electrical impedance tomography images and ultrasound images may be shared with no participant identification.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation dIstribution and effeCt of posTural Lateralization On Traumatic Lung injuRY: a Physiological Study
- ClinicalTrials.gov ID
- NCT06196125
- Acronym / sponsor ID
- VICTORY / 23-231
- Conditions
- Trauma Chest, Mechanical Ventilation
- Keywords
- chest trauma, mechanical ventilation, positional changes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be conducted while the patient is partially assisted on a breathing machine and have been clinically indicated to mobilize as tolerated while in the weaning process in the ICU.
The investigators will use EIT to visualize where air goes in the patient's lungs and lung ultrasonography to visualize lung inflation in specific areas. EIT is a measurement often used in the ICU since it allows easy visualization and is a non-invasive technique. The sensors measure electrical current changes during inspiration and expiration and will not cause any pain or radiation concerns. The EIT belt (3-cm diameter) will be placed around the chest without causing adverse event/discomfort/pain to the injured thorax area and recording will occur for 5 minutes during the first supine position, then 30 minutes for each side of left and right lateral position using the 30 Degree wedge pillow to support. The pillow is routinely applied to every ICU patient when eligible to be positioned on their side. As routine practice, patients are turned on each side every 2 hours to prevent pressure sores. Lastly, the investigators will do a final 30-minute recording when the patient is turned back onto their back. The duration of study will be approximately 95 minutes per session, which includes placing the patient in the four positions (on the back, the left side, the right side and returning to the back). The investigators will perform the same protocol at three different times when they are at different stages of weaning off the breathing machine: i) during partially assisted breathing, ii.) during a high setting of spontaneous breathing and iii.) during low setting of spontaneous breathing). These 3 breathing machine's settings indicate the patient is on the pathway of weaning off the breathing machine. The total study hours will be 4.75 hours (3 sessions) and each breathing machine's setting will be adjusted by clinical team over time. The investigators will proceed with the measurements only with agreement from the clinical team. The investigators will analyze the data collected offline with a dedicated software afterwards.
This study may require arterial blood gas analysis at baseline and after the procedure, only if there is an arterial line in place. The information from the sample provides the investigator the status of participant's breathing and breathing machine settings. It allows for any appropriate adjustments to the breathing machine. After these study procedures are completed, data will also be collected from the participant's chart and combined with relevant information from the breathing machine settings and vital functions at each stage of position changes. Confidentiality will be maintained throughout the entire study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated mechanically ventilated patients with thoracic trauma. | – | Other: Four body positionsIntubated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be selected from intensive care units.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four body positionsPhysiological 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. | Other | Intubated mechanically ventilated patients with thoracic trauma. |
Primary outcome
Difference in ventilation distribution (%)
Time frame: 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)
Time frame: 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).
5 secondary outcomes
Patterns of ventilation distribution.
Time frame: 95 minutes
Correlation between ventilation distribution and lung aeration patterns.
Time frame: 95 minutes
Quantify Pendelluft in different body positions
Time frame: 95 minutes
Correlation of various traumatic lung injuries to ventilation distribution.
Time frame: 95 minutes
Correlation of duration of mechanical ventilation to lung aeration patterns.
Time frame: 95 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided. Electrical impedance tomography images and ultrasound images may be shared with no participant identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Brochard, MD principal investigator
St. Michael's hospital, Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Chest and Mechanical Ventilation, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in ventilation distribution (%) (time frame: 4.75 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.