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Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP). (Opti-PEP)

Primary Purpose

Thoracic Injuries, Non-invasive Ventilation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung Ultrasound for PEEP setting
Non invasive ventilation session
Arterial blood gas
Interview on pain and comfort
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thoracic Injuries focused on measuring thoracic injuries, non-invasive ventilation, Positive End Expiratory Pressure, Ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session.

    The conventional group will benefit from the NIV under the current terms.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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
    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)
    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)
    Comparaison of the PaO2/FiO2 ratio in both groups
    Comparaison of the PaO2/FiO2 ratio in both groups
    Comparaison of the incidence rate of respiratory aggravation in the 2 groups
    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
    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
    PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation
    PaO2/FiO2 ratio in both groups in patients with pleural effusion
    PaO2/FiO2 ratio in the 2 groups in patients with pleural effusion

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 2, 2023
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06072339
    Brief Title
    Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP).
    Acronym
    Opti-PEP
    Official 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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 7, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Injuries, Non-invasive Ventilation
    Keywords
    thoracic injuries, non-invasive ventilation, Positive End Expiratory Pressure, Ultrasonography

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    open-labeled, controlled, randomized study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The conventional group will benefit from the NIV under the current terms.
    Intervention Type
    Other
    Intervention Name(s)
    Lung Ultrasound for PEEP setting
    Intervention Description
    NIV is started and adjusted by the physiotherapist. For the adjustment of PEEP, the ultrasound probe is placed on the thorax, facing the intercostal space having obtained the highest score during the initial LUS (synonym of the worst pulmonary aeration) and the images observed in real time. PEEP is increased until the physiotherapist cannot see any additional benefit on pulmonary aeration or appearance of a patient discomfort or an increasing of air leaks.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non invasive ventilation session
    Intervention Description
    The session will be done via a mouthpiece preferably, or a face mask if it is impossible for the patient to close their mouth properly or to hold the mouthpiece. The duration of the NIV session will be defined by the prescribing doctor (usually between 30 and 60 minutes), without being able to be less than 30 minutes. The session will be stopped in the event of the appearance of one of the contraindications to NIV mentioned above.
    Intervention Type
    Biological
    Intervention Name(s)
    Arterial blood gas
    Intervention Description
    Arterial blood gas will be done at inclusion, at Visit 1 (at the 30th minute from the start of the 1st Non-invasive ventilation session) and at Visit 2 (at the 60th minute from the start of the 1st Non-invasive ventilation session) in both groups of patients in order to calculate the Pa02/Fi02 ratio.
    Intervention Type
    Other
    Intervention Name(s)
    Interview on pain and comfort
    Intervention Description
    The investigator physiotherapist interviews the participant to measure pain and comfort scores using a visual analogue scale (score from 0 to 10).
    Primary Outcome Measure Information:
    Title
    PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups
    Description
    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.
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session
    Secondary Outcome Measure Information:
    Title
    Comparaison of the Lung Ultrasound Score (LUS) in both groups
    Description
    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.
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session
    Title
    Comparaison of the PEEP value set at the start of the non-invasive ventilation session
    Description
    Comparaison of the PEEP value set (in cmH2O) in both groups
    Time Frame
    At the start of the non-invasive ventilation session
    Title
    Comparaison of the confort value in both groups
    Description
    Comparaison of the confort value in both groups using the Confort Visual Analog scale (from 0 to 10)
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session
    Title
    Comparaison of the pain value in both groups
    Description
    Comparaison of the pain value in both groups using the Pain Visual Analog scale (from 0 to 10)
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session
    Title
    Comparaison of the PaO2/FiO2 ratio in both groups
    Description
    Comparaison of the PaO2/FiO2 ratio in both groups
    Time Frame
    1 hour after the end of the 1st non-invasive ventilation session
    Title
    Comparaison of the incidence rate of respiratory aggravation in the 2 groups
    Description
    Comparaison of the incidence rate of respiratory aggravation in the 2 groups
    Time Frame
    Until discharge from intensive care/continuous care or until maximum D7.
    Title
    Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of non-invasive ventilation is possible
    Description
    Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of NIV is possible
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session
    Title
    PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation
    Description
    PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session
    Title
    PaO2/FiO2 ratio in both groups in patients with pleural effusion
    Description
    PaO2/FiO2 ratio in the 2 groups in patients with pleural effusion
    Time Frame
    at the 30th minute from the start of the 1st Non-invasive ventilation session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David CHAPEAU, Physiotherapist
    Phone
    0467332688
    Email
    d-chapeau@chu-montpellier.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP).

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