Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05104606

Speckle Tracking and Inhaled Nitric Oxide 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

ARDS Right Ventricle Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEE

Other

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.

TTE

Other

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

Primary outcomes

  1. Variation from baseline of systolic function after iNO administration

    Time frame: 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 outcomes

  1. Variation from baseline of systolic function after iNO administration

    Time frame: at 1 hour

    Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO responders

  2. Variation from baseline of systolic function after iNO administration

    Time frame: at 1 hour

    Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO nonresponders

  3. Variation from baseline of systolic function after iNO administration

    Time frame: at 2 hours

    Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO responders

  4. Variation from baseline of systolic function after iNO administration

    Time frame: at 2 hours

    Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO nonresponders

  5. Variation from baseline of systolic function after iNO administration

    Time frame: at 24 hours

    Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO responders

  6. Variation from baseline of systolic function after iNO administration

    Time frame: at 24 hours

    Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO nonresponders

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: NOSPECKLE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 3, 2021
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.