Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome

NCT ID: NCT05104606

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2025-12-31

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.

Conditions

ARDS; Right Ventricle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

TEE

The intervention within the framework of the protocol will consist, for the needs of the study, in performing 2 TEE and 5 TTE in 24 hours after

For TEE:

• The first TEE will allow us to evaluate the right ventricle, to look for the existence of a acute cor pulmonale, to evaluate the patient's blood volume as recommended during the management of ARDS. If the patient is included in the study, our intervention will consist in leaving this TEE in place in order to perform measurements at H0, 30min, H1 and H2 after iNO administration.
• The second TEE will be performed at H24 to performed new measurements.

Intervention Type: OTHER

TTE

For TTE:

• The TTEs will allow us to evaluate the anatomy of the right ventricle, to estimate the systolic pulmonary artery pressure, to calculate the cardiac output and to measure the conventional parameters of the right ventricular systolic function. This noninvasive examination will be repeated at 30 min, H1, H2, and H24 after iNO administration

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, , France

Countries

France

Other Identifiers

PI2021_843_0066

Identifier Type: -

Identifier Source: org_study_id