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Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05104606
Acronym
NOSPECKLE
Enrollment
64
Registered
2021-11-03
Start date
2021-11-02
Completion date
2025-12-31
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Right Ventricle

Keywords

speckle tracking, ARDS, right ventricle, iNO, strain

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.

Interventions

OTHERTEE

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.

OTHERTTE

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Variation from baseline of systolic function after iNO administration30 minutesSystolic 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

MeasureTime frameDescription
Variation from baseline of systolic function after iNO administrationat 1 hourRight ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO responders

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026