NOSPECKLE: Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05104606

Collaborator

(none)

Enrollment

Location

24.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS Right Ventricle	Other: TEE Other: TTE	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome

Actual Study Start Date :

Nov 2, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Variation from baseline of systolic function after iNO administration [30 minutes]
Systolic function will be assessed with "in speckle tracking RV" in the presence or not of a response to iNO 30 minutes after its administration, Systolic function will be assessed with "in speckle tracking RV" in patients with moderate to severe ARDS under mechanical ventilation.

Secondary Outcome Measures

Variation from baseline of systolic function after iNO administration [at 1 hour]
Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO responders
Variation from baseline of systolic function after iNO administration [at 1 hour]
Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO nonresponders
Variation from baseline of systolic function after iNO administration [at 2 hours]
Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO responders
Variation from baseline of systolic function after iNO administration [at 2 hours]
Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO nonresponders
Variation from baseline of systolic function after iNO administration [at 24 hours]
Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO responders
Variation from baseline of systolic function after iNO administration [at 24 hours]
Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO nonresponders

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.