Clinical trial NCT05104606: Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome
Official title: Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ARDS
Right Ventricle
Keywords: speckle tracking
ARDS
right ventricle
iNO
strain
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Acute cor pulmonale is one of deadly complications of mechanically ventilated acute respiratory distress syndrome (ARDS), which can lead to right ventricular dysfunction and worsen the hemodynamics of the patient. For several years, transthoracic (TTE) and transesophageal echocardiography (TEE) have replaced the pulmonary artery catheter to monitor cardiac function reliably and non-invasively.

Speckle tracking is an echocardiographic technique that allows a two-dimensional strain (2D) analysis of right ventricular systolic function. Right ventricular global strain (RVGLS) is a strain parameter, allowing an early and more accurate diagnosis of right ventricular dysfunction than conventional parameters.

This project will consist of performing TTE and TEE measurements at H0, 30min, H1, H2, and H24 after iNO administration in patient with ARDS under mechanical ventilation. The patient will be declared responder to iNO, if there is an increase of more than 20% of the PaO2/FiO2. 30 minutes after a dose of 10ppm of iNO.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age \> 18 years)
* Hospitalized in the intensive care and post-operative care unit of the Amiens-Picardie University Hospital
* Patient with ARDS (defined by the Berlin criteria) requiring mechanical ventilation with a P/F ratio \< 200 and requiring iNO
* Beneficiary of social security
* Signature of the consent to participate in the study by the patient or, if unconscious, his legal representative/next of kin

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Contraindications to TEE (major upper gastro-intestinal surgery, mediastinal radiotherapy, active esophagitis, esophageal varices)
* Contraindications to the placement of an esophageal probe (recent upper gastro-intestinal surgery, active ulcer, active esophagitis)
* Presence of atrial fibrillation on echocardiographic examinations
* Contraindications to the administration of iNO
* Patients with chronic treatment allowing pulmonary arterial vasodilatation by sildenafil.

Primary outcomes:
measure: Variation from baseline of systolic function after iNO administration
timeFrame: 30 minutes
Secondary outcomes:
measure: Variation from baseline of systolic function after iNO administration
timeFrame: at 1 hour
measure: Variation from baseline of systolic function after iNO administration
timeFrame: at 1 hour
measure: Variation from baseline of systolic function after iNO administration
timeFrame: at 2 hours
measure: Variation from baseline of systolic function after iNO administration
timeFrame: at 2 hours
measure: Variation from baseline of systolic function after iNO administration
timeFrame: at 24 hours
measure: Variation from baseline of systolic function after iNO administration
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References: