Non-invasive Ventilation Clinical Trial
— Opti-PEPOfficial title:
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).
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 7, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | UH of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups | 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. |
at the 30th minute from the start of the 1st Non-invasive ventilation session | |
Secondary | Comparaison of the Lung Ultrasound Score (LUS) in both groups | 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 Moderate loss of lung aeration corresponding to multiple well-defined B lines or spaced ultrasound lung called 'cornet-tail artifact" Severe loss of lung aeration corresponding to multiple coalescent B lines or multiple abutting ultrasound lung cornet-tails issued from the pleural line 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. |
at the 30th minute from the start of the 1st Non-invasive ventilation session | |
Secondary | Comparaison of the PEEP value set at the start of the non-invasive ventilation session | Comparaison of the PEEP value set (in cmH2O) in both groups | At the start of the non-invasive ventilation session | |
Secondary | Comparaison of the confort value in both groups | Comparaison of the confort value in both groups using the Confort Visual Analog scale (from 0 to 10) | at the 30th minute from the start of the 1st Non-invasive ventilation session | |
Secondary | Comparaison of the pain value in both groups | Comparaison of the pain value in both groups using the Pain Visual Analog scale (from 0 to 10) | at the 30th minute from the start of the 1st Non-invasive ventilation session | |
Secondary | Comparaison of the PaO2/FiO2 ratio in both groups | Comparaison of the PaO2/FiO2 ratio in both groups | 1 hour after the end of the 1st non-invasive ventilation session | |
Secondary | Comparaison of the incidence rate of respiratory aggravation in the 2 groups | Comparaison of the incidence rate of respiratory aggravation in the 2 groups | Until discharge from intensive care/continuous care or until maximum D7. | |
Secondary | Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of non-invasive ventilation is possible | Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of NIV is possible | at the 30th minute from the start of the 1st Non-invasive ventilation session | |
Secondary | PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation | 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 | |
Secondary | PaO2/FiO2 ratio in both groups in patients with pleural effusion | PaO2/FiO2 ratio in the 2 groups in patients with pleural effusion | at the 30th minute from the start of the 1st Non-invasive ventilation session |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05756387 -
Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
|
||
Not yet recruiting |
NCT06259565 -
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
|
Phase 3 | |
Completed |
NCT02973373 -
MRI of the Chest Under High Frequency Ventilation
|
N/A | |
Recruiting |
NCT04054622 -
Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise
|
||
Completed |
NCT03859947 -
High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis
|
||
Completed |
NCT03149835 -
NIV Reduces CBF in COPD Patients Without Cognitive Function
|
N/A | |
Recruiting |
NCT04036175 -
Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.
|
N/A | |
Recruiting |
NCT02712190 -
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
|
N/A | |
Not yet recruiting |
NCT05435183 -
Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving Carbon Dioxide Clearance in AECOPD Patients
|
N/A | |
Recruiting |
NCT05796297 -
Clinical Impact of Patient-ventilator Asynchrony
|
||
Not yet recruiting |
NCT05850195 -
Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure
|
||
Not yet recruiting |
NCT05448417 -
Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects
|
N/A | |
Completed |
NCT05031650 -
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
|
N/A | |
Completed |
NCT03130361 -
Wearable Noninvasive Positive Pressure Ventilation Device in COPD
|
N/A | |
Completed |
NCT04178694 -
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
|
N/A | |
Not yet recruiting |
NCT05721833 -
Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving CO2 Clearance in COPD Patients
|
N/A | |
Not yet recruiting |
NCT05706467 -
The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
|
N/A | |
Recruiting |
NCT01961245 -
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
|
N/A | |
Recruiting |
NCT03978221 -
Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.
|
N/A | |
Completed |
NCT04884828 -
Asynchronies in NIV With External Gas
|