Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP).
- Conditions
- Thoracic InjuriesNon-invasive Ventilation
- Interventions
- Procedure: Non invasive ventilation sessionOther: Lung Ultrasound for PEEP settingBiological: Arterial blood gasOther: Interview on pain and comfort
- Registration Number
- NCT06072339
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arterial blood gas The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session. Control Non invasive ventilation session The conventional group will benefit from the NIV under the current terms. Control Interview on pain and comfort The conventional group will benefit from the NIV under the current terms. Experimental Non invasive ventilation session The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session. Experimental Lung Ultrasound for PEEP setting The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session. Experimental Interview on pain and comfort The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session. Control Arterial blood gas The conventional group will benefit from the NIV under the current terms.
- Primary Outcome Measures
Name Time Method PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups 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 Outcome Measures
Name Time Method 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 Lung Ultrasound Score (LUS) in both groups. The LUS ranges from 0 to 36. Rib cage is divided into 12 areas (6 for each side) and each area is assessed according to the following scale:
0: Normal aeration corresponding to presence of lung sliding with A lines or fewer than two isolated B lines
1. Moderate loss of lung aeration corresponding to multiple well-defined B lines or spaced ultrasound lung called 'cornet-tail artifact"
2. Severe loss of lung aeration corresponding to multiple coalescent B lines or multiple abutting ultrasound lung cornet-tails issued from the pleural line
3. Lung consolidation corresponding to presence of a tissue pattern containing hyperechoic punctiform images representative of air bronchograms. Presence or absence of regional pulmanory blood flow and/or dynamic bronchograms.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 PEEP value set (in cmH2O) in both groups
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 confort value in both groups using the Confort Visual Analog scale (from 0 to 10)
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 pain value in both groups using the Pain Visual Analog scale (from 0 to 10)
Comparaison of the PaO2/FiO2 ratio in both groups 1 hour after the end of the 1st non-invasive ventilation session Comparaison of the PaO2/FiO2 ratio in both groups
Comparaison of the incidence rate of respiratory aggravation in the 2 groups Until discharge from intensive care/continuous care or until maximum D7. Comparaison of the incidence rate of respiratory aggravation in the 2 groups
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 Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of NIV is possible
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 pulmonary consolidation
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 PaO2/FiO2 ratio in the 2 groups in patients with pleural effusion
Trial Locations
- Locations (1)
UH of Montpellier
🇫🇷Montpellier, France