Clinical trial NCT04961437: Impact of Dyspnea, Regional Lung Ventilation, and Diaphragmatic Function During de Novo Acute Respiratory Failure
Official title: Evaluation of Dyspnea, Pulmonary VentIlation and DIaphragmatic Function in de Novo Adult Acute Respiratory Failure.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
Keywords: Acute respiratory failure
diaphragm
dyspnea
EIT
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with de novo acute respiratory failure

Brief summary: Modern management of acute respiratory failure aims to relieve dyspnea and anxiety by providing a non-invasive respiratory support. This approach tries to avoid endotracheal intubation, patient self inflicted lung injuries (PSILI) and diaphragmatic dysfunction. The present study aims to evaluate dyspnea, pulmonary regional ventilation and diaphragmatic function in patients with hypoxemic acute respiratory failure by different observations, and to bring risk factor for intubation out.

Detailed description: Patients aged of 18 years or more, presenting with an acute respiratory failure without hypercapnia will be included in the study. Clinical and biological variables, dyspnea assessment, regional lung ventilation (electrical impedance tomography) and diaphragm function (ultrasound) will be evaluated at inclusion and at 2 hours, 4 hours and 48 hours after inclusion. In case of intubation, diaphragmatic function will be also evaluated with phrenic nerve stimulation technique.

Primary endpoint is intubation at day 7. Secondary endpoints are measurement of dyspnea, pulmonary ventilation and diaphragmatic function, also ventilator free days, ICU length of stay and mortality.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Acute respiratory insufficiency defined by the three following items :

  1. PaO2/ FiO2 \<300
  2. Respiratory rate \> 25/min
  3. Oxygen support \> 10L/min or High Flow nasal oxygen (HFNO)
* Non opposition by the patient to be included
* Social insurance

Exclusion Criteria:

* Respiratory acidosis (pH \< 7,35 PaCO2 \> 45mmHg or 6kPa)
* Chronic respiratory disease ( COPD, bronchiectasis...)
* Cardiogenic Acute lung oedema
* Non intubation decision at randomisation
* Contraindication for Electro-impedance tomography-belt placement (chest trauma with rib fractures, thoracic wound, chest tube).
* Uncommunicative patient (Glasgow coma scale \<12)
* Guardianship or curators for vulnerable patients.

Primary outcomes:
measure: Oro-tracheal intubation
timeFrame: 7 days after admission in the ICU
Secondary outcomes:
measure: Diaphragmatic function
timeFrame: 2 days after inclusion
measure: Diaphragmatic function
timeFrame: 2 days after inclusion
measure: lung regional ventilation
timeFrame: 2 days after inclusion
measure: Dyspnea evaluation
timeFrame: 28 days after inclusion
measure: Dyspnea evaluation
timeFrame: 28 days after inclusion
measure: Mechanical ventilation duration
timeFrame: 28 days after inclusion
measure: ICU length of stay
timeFrame: 28 days after inclusion
measure: ICU mortality
timeFrame: 28 days after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Martin DRES, MD PhD
role: STUDY_DIRECTOR
References: