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

Primary Purpose

ARDS, Right Ventricle

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TEE
TTE
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ARDS focused on measuring speckle tracking, ARDS, right ventricle, iNO, strain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Amiens PicardieRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
October 12, 2021
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05104606
Brief Title
Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome
Acronym
NOSPECKLE
Official Title
Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Right Ventricle
Keywords
speckle tracking, ARDS, right ventricle, iNO, strain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
TEE
Intervention Description
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
Intervention Name(s)
TTE
Intervention Description
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 Outcome Measure Information:
Title
Variation from baseline of systolic function after iNO administration
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Variation from baseline of systolic function after iNO administration
Description
Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO responders
Time Frame
at 1 hour
Title
Variation from baseline of systolic function after iNO administration
Description
Right ventricular function is assessed by speckle tracking at 1 hour after iNO administration in iNO nonresponders
Time Frame
at 1 hour
Title
Variation from baseline of systolic function after iNO administration
Description
Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO responders
Time Frame
at 2 hours
Title
Variation from baseline of systolic function after iNO administration
Description
Right ventricular function is assessed by speckle tracking at 2 hours after iNO administration in iNO nonresponders
Time Frame
at 2 hours
Title
Variation from baseline of systolic function after iNO administration
Description
Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO responders
Time Frame
at 24 hours
Title
Variation from baseline of systolic function after iNO administration
Description
Right ventricular function is assessed by speckle tracking at 24 hours after iNO administration in iNO nonresponders
Time Frame
at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Beyls, MD
Phone
03 22 08 78 66
Email
beyls.christophe@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Beyls, MD
Phone
0322087866
Email
Beyls.Christophe@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Osama ABOU ARAB, MD
First Name & Middle Initial & Last Name & Degree
Yazine MAHJOUB, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome

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