ARDSNOSPECKLENCT05104606
Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome
A study testing TEE and TTE in people with ARDS and Right Ventricle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Right Ventricle
- What is being tested?
- TEE and TTE
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- ARDS, Right Ventricle
- Being tested
- TEE, TTE
- Keywords
- speckle tracking, ARDS, right ventricle, iNO, strain
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEEOther
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.
TTEOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start2 Nov 2021
- Primary completion1 Dec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104606
- Sponsor's protocol ID
- PI2021_843_0066
- Acronym
- NOSPECKLE
- Status last verified
- May 2025
- First submitted
- 12 Oct 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05104606
- Acronym / sponsor ID
- NOSPECKLE / PI2021_843_0066
- Conditions
- ARDS, Right Ventricle
- Keywords
- speckle tracking, ARDS, right ventricle, iNO, strain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEEThe 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. | Other | – |
| TTEFor 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 | Other | – |
Primary outcome
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.
6 secondary outcomes
Variation from baseline of systolic function after iNO administration
Time frame: at 1 hour
Variation from baseline of systolic function after iNO administration
Time frame: at 1 hour
Variation from baseline of systolic function after iNO administration
Time frame: at 2 hours
Variation from baseline of systolic function after iNO administration
Time frame: at 2 hours
Variation from baseline of systolic function after iNO administration
Time frame: at 24 hours
Variation from baseline of systolic function after iNO administration
Time frame: at 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEE and TTE in people with ARDS and Right Ventricle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation from baseline of systolic function after iNO administration (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.