RecruitingNot ApplicableNCT06072339

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

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).


Sponsor

University Hospital, Montpellier

Enrollment

40 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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

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Interventions

OTHERLung Ultrasound for PEEP setting

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.

PROCEDURENon invasive ventilation session

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.

BIOLOGICALArterial blood gas

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.

OTHERInterview on pain and comfort

The investigator physiotherapist interviews the participant to measure pain and comfort scores using a visual analogue scale (score from 0 to 10).


Locations(1)

UH of Montpellier

Montpellier, France

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NCT06072339


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