Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation : Randomized Controlled Study (Opti-PEP).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups
Study Overview
Brief Summary
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies.Patients may be included if they present with acute respiratory failure related to blunt chest trauma.The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the adjustment of Positive End Expiratory Pressure (PEEP) during the 1st session. The conventional group will benefit from the non-invasive ventilation according to the current care.
Detailed Description
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies. Patients may be included if they are admitted to intensive care unit or continuing care unit and present with acute respiratory failure related to blunt chest trauma. We will not include patients with another indication for non-invasive ventilation, immediately needing invasive ventilation, a contraindication to non invasive ventilation or an estimated length of stay less than or equal to 48 hours.
Both groups will be treated with non-ivasive ventilation according to the medical prescription. The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the adjustment of PEEP during the 1st session. The conventional group will benefit from the non-invasive ventilation according to the usual care. The other non-invasive ventilation settings will be chosen with the same method in both groups.
The main endpoint will be the PaO2/FiO2 ratio (Arterial oxygen pressure / inspired fraction of oxygen) after 30 min of non-invasive ventilation treatment. This ratio is the best reflection of the patient oxygenation and currently used for respiratory therapies studies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 or more
- •Admitted to intensive care or continuing care for 72 hours or less for blunt chest trauma, defined by the presence of at least one of the following elements on the initial CT scan: fracture(s) of rib(s) / fracture(s) of the sternum / pulmonary contusion / hemothorax
- •Acute hypoxemic respiratory failure defined by the administration of oxygen at least 3 L/min with nasal cannula or FiO2≥30% if high flow oxygen therapy.
- •Patient with a functional arterial catheter for blood tests
Exclusion Criteria
- •Acute respiratory distress, defined by the presence of at least one of the following clinical signs: respiratory rate ˃ 35 / use of accessory inspirators / paradoxal abdominal or thoracic motion
- •Imminent need for invasive mechanical ventilation
- •Usual contraindication to non-invasive ventilation (undrained pneumothorax, trauma to the face, vigilance disorders, digestive bleeding, hemodynamic instability, intolerance)
- •Hypercapnia (PaCO2˃45mmHg)
- •Patient unable to cooperate, communicate
- •Therapeutic limitation
- •Expected length of stay ≤ 48h
- •Severe head trauma
- •Pregnant or breastfeeding women
- •Participation in other clinical research related to respiratory failure/respiratory therapy
- •Vulnerable people
- •Protected adults, under guardianship or curatorship, or unable to give consent
- •Non-affiliated person or beneficiary of a social security scheme
- •Absence of free, informed and written consent, signed by the participant and the investigator
Arms & Interventions
Experimental
The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session.
Intervention: Interview on pain and comfort (Other)
Control
The conventional group will benefit from the NIV under the current terms.
Intervention: Arterial blood gas (Biological)
Control
The conventional group will benefit from the NIV under the current terms.
Intervention: Interview on pain and comfort (Other)
Experimental
The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session.
Intervention: Arterial blood gas (Biological)
Experimental
The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session.
Intervention: Lung Ultrasound for PEEP setting (Other)
Experimental
The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session.
Intervention: Non invasive ventilation session (Procedure)
Control
The conventional group will benefit from the NIV under the current terms.
Intervention: Non invasive ventilation session (Procedure)
Outcomes
Primary Outcomes
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups
Time Frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups. This PaO2/FiO2 ratio is now the benchmark for qualifying the severity of the respiratory impairment or measuring the response to a mechanical ventilation strategy aimed at improving oxygenation.
Secondary Outcomes
- Comparaison of the Lung Ultrasound Score (LUS) in both groups(at the 30th minute from the start of the 1st Non-invasive ventilation session)
- Comparaison of the PEEP value set at the start of the non-invasive ventilation session(At the start of the non-invasive ventilation session)
- Comparaison of the confort value in both groups(at the 30th minute from the start of the 1st Non-invasive ventilation session)
- Comparaison of the pain value in both groups(at the 30th minute from the start of the 1st Non-invasive ventilation session)
- Comparaison of the PaO2/FiO2 ratio in both groups(1 hour after the end of the 1st non-invasive ventilation session)
- Comparaison of the incidence rate of respiratory aggravation in the 2 groups(Until discharge from intensive care/continuous care or until maximum D7.)
- Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of non-invasive ventilation is possible(at the 30th minute from the start of the 1st Non-invasive ventilation session)
- PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation(at the 30th minute from the start of the 1st Non-invasive ventilation session)
- PaO2/FiO2 ratio in both groups in patients with pleural effusion(at the 30th minute from the start of the 1st Non-invasive ventilation session)