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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).

NCT06072339 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

OTHER

Lung 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.

PROCEDURE

Non 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.

BIOLOGICAL

Arterial 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.

OTHER

Interview 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).

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-12-19
Completion
2025-12-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072339 on ClinicalTrials.gov