Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients

NCT06735872 | Recruiting

• 1 other identifier: 69HCL24_1116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chest trauma is common in traumatology. Its management is based on ventilatory therapies, among which non-invasive ventilation (NIV) is commonly used. Some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing mortality. However, these studies are old and underpowered. High flow oxygen therapy (HFO), which is frequently used in everyday practice, has only one study in chest trauma. There is still a lack of data to really understand the effects of these techniques on the injured lung after trauma. Therefore, the investigators want to do a NIV or HFO session and directly assess the effects on participants' lungs by doing a CT at the end of the session. This is a procedure carried out within five days of the initial trauma and consists of either a 10-minute session of non-invasive ventilation or a 10-minute session of high-flow oxygen therapy, depending on which arm the participant is allocated to. Two chest CTs will be performed: the first as part of usual care before the non-invasive ventilation session or high flow oxygen therapy session, and the second immediately after the 10-minute session. The investigator's objective is to demonstrate an improvement in lung recruitment with NIV or HFO using CT imaging.

Conditions

Lung Trauma; Lung Contusion

Outcome Measures

Primary Outcomes (1)

• lung volume

  The primary outcome is evaluated by a quantitative method to compare lung volumes before and after ventilations sessions. The aim is to measure pulmonary recruitment which corresponds to the lung volume reaerated by ventilatory techniques (NIV and HFO), meaning the difference between the non-aerated lung volume between after and before the intervention. Thus, recruitment includes the partial or total re-aeration of lung areas initially not aerated before the intervention. The senior radiologist determine the non aerated volumes on mm3 thanks to a dedicated software. We will use a semi-automatic segmentation can be carried out quickly and reproducibly.

  At day 0

Study Arms (2)

Non invasive ventilation

EXPERIMENTAL

This group will receive a unique 10-minute session of non invasive ventilation with standard parameters directly on the CT table. The treatment will be delivered via a naso-buccal mask.

Procedure: Non invasive ventilation (NIV)

High flow oxygen therapy

EXPERIMENTAL

This group will receive a unique 10-minute session of high flow oxygen directly on the CT table. The treatment will be delivered via a nasal cannula

Procedure: High flow oxygen therapy (HFO)

Interventions

Non invasive ventilation (NIV) PROCEDURE

This group will receive a unique 10-minute session of non invasive ventilation with standard parameters directly on the CT table. The treatment will be delivered via a naso-buccal mask. Prior to treatment, each participant will have a planned standard care chest CT. During the session, a senior intensivist watching for participant's comfort and safety.

Non invasive ventilation

High flow oxygen therapy (HFO) PROCEDURE

This group will receive a unique 10-minute session of high flow oxygen directly on the CT table. The treatment will be delivered via a nasal cannula. Prior to treatment, each participant will have a planned standard care chest CT. During the session, a senior intensivist watching for participant's comfort and safety.

High flow oxygen therapy

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old
• Chest trauma \< 5 days
• At least 3 ribs fracture on initial CT-scan
• Need of oxygen moderated to maintain monitoring oxygen saturation Sp02 \> 92% or partial pressure of arterial oxygen Pa02/ Fraction of inspired oxygen FiO2 \> 200
• Intensive Care Unit admission
• Need a chest CT control during the five first days after the trauma

You may not qualify if:

• Patient intubated or with respiratory failure : measured or estimated Pa02/FiO2 \< 200 or indication for intubation (several with respiratory rate \> 35/min, abundant tracheal secretions, significant increase in work of accessory respiratory muscles on inspiration, signs of respiratory exhaustion on arterial blood gas with The potential of Hydrogen pH \< 7,3 or PaCO2 \> 50 mmHg, severe hypoxemia with PaO2/FiO2 ratio \< 100 or desaturation \< 88% for more than 5 minutes)
• Inability to maintain 10 seconds of apnoea required for scan acquisition
• Patient treated with ventilatory support by NIV or HFO in the 12 hours prior the investigation
• Uncontrolled circulatory failure with need for introduction of Noradrenaline \> 0,15 ug/kg/min
• Uncontrolled neurological failure with Glasgow Coma Scale (CGS \< 15
• Unstable facial trauma or with pneumocephalus or basilar skull trauma
• Large, undrained pneumothorax with lateral separation at the level of the hilum \> 2 cm and extensive throughout the axillary line
• Patients with identified cognitive impairment
• Persons deprived of liberty, persons under protective measures
• Persons not affiliated to a social security insurance
• Current pregnancy or breastfeeding
• Refusal to participate in the study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Edouard Herriot

Lyon, Rhône, 69003, France

RECRUITING

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Stanislas ABRARD, MD

CONTACT

04 72 11 69 44; stanislas.abrard@chu-lyon.fr

Valerie Cerro

CONTACT

valerie.cerro01@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is experimental, descriptive, prospective and monocentric. The design is with two parallel groups where each patient is his own control. That's why there is no control group. There are two groups: one receiving ten minutes of non invasive ventilation and the other one receiving ten minutes of high flow oxygen therapy. After the treatment, each participant will have an additional chest CT to determine lung volumes. To determine which group the participant is in, we use a randomisation without stratification.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

FR (1)