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

NCT06072339 | Recruiting

• 1 other identifier: RECHMPL22_0556
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Injuries; Non-invasive Ventilation

Keywords

thoracic injuries; non-invasive ventilation; Positive End Expiratory Pressure; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: Lung Ultrasound for PEEP setting; Procedure: Non invasive ventilation session; Biological: Arterial blood gas; Other: Interview on pain and comfort

Control

ACTIVE COMPARATOR

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

Procedure: Non invasive ventilation session; Biological: Arterial blood gas; Other: Interview on pain and comfort

Interventions

Lung Ultrasound for PEEP setting OTHER

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.

Experimental

Non invasive ventilation session PROCEDURE

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.

Control; Experimental

Arterial blood gas BIOLOGICAL

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.

Control; Experimental

Interview on pain and comfort OTHER

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

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Thoracic Injuries

Interventions

Blood Gas Analysis; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Central Study Contacts

David CHAPEAU, Physiotherapist

CONTACT

0467332688; d-chapeau@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-labeled, controlled, randomized study

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: December 19, 2023
• Primary Completion: December 19, 2025
• Study Completion: December 26, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

FR (1)