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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ARDS; Right Ventricle
• Intervention / Treatment: Other: TEE; Other: TTE

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation from baseline of systolic function after iNO administration	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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation from baseline of systolic function after iNO administration	Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO responders	at 1 hour
Variation from baseline of systolic function after iNO administration	Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO nonresponders	at 1 hour
Variation from baseline of systolic function after iNO administration	Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO responders	at 2 hours
Variation from baseline of systolic function after iNO administration	Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO nonresponders	at 2 hours
Variation from baseline of systolic function after iNO administration	Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO responders	at 24 hours
Variation from baseline of systolic function after iNO administration	Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO nonresponders	at 24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ARDS; right ventricle; iNO; speckle tracking; strain
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PI2021_843_0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No