PneumoniaECHOVAPNCT03279887
Lung Ultrasonography After Major Cardiac Surgery
An observational study of Pneumonia and Cardio/Pulm: Respiratory Failure, run by Groupe Hospitalier Pitie-Salpetriere.
Trial summary
Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pneumonia, Cardio/Pulm: Respiratory Failure, Cardiopulmonary Bypass
- What is being tested?
- Lung Ultrasound
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute respiratory failure after cardiac surgery and hospitalized in the surgical Intensive Care Unit of ICU of Cardiology Institute, Pitié Salpêtrière University Hospital, Paris, France
Who may be able to join
- Cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) less than 3 days before
- At least one component suggestive of ARF:
- If mechanical ventilation, a PaO2 / FiO2 ratio <200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,
- If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea> 25/min, upper or intercostal swallowing, abdominal swing ...), SpO2 < 90% or PaO2 <60 mmHg despite oxygen therapy ≥ 3L/min.
Who cannot join
- Minor patients
- Pregnancy
- Sleep apnea syndrome
- Participation refusal
About this study
Official title: Usefulness of Lung Ultrasonography for Diagnosis of Pneumonia After Major Cardiac Surgery: a Pilot Study
Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. This study investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.
- Being tested
- Lung Ultrasound
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Post operative respiratory failure | Patients with acute respiratory failure (ARF) less than 72 hours after a major cardiac surgery with cardiopulmonary bypass
ARF was defined as one of the following conditions:
* If mechanical ventilation, a partial pressure of oxygen/ inspired oxygen fraction ratio (PaO2/FiO2) < 200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,
* If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea> 25/min, upper or intercostal swallowing, abdominal swing ...), pulse oximetry (SpO2) < 90% or PaO2 <60 mmHg despite oxygen therapy ≥ 3 L/min. Receives: Diagnostic Test: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final diagnosis of pneumonia
Pneumonia or excluded pneumonia, was determined by consensus of 3 investigators, after an independent post hoc review of the medical records. Pneumonia diagnosis was based on concordance of clinical and radiological criteria (≥ 2 criteria including fever> 38.5 ° C or T <36 ° C, leukocytosis> 10 ^ 9 / L or leukopenia <4.10 ^ 8 / L, purulent tracheal secretions and the appearance or persistence of an infiltrate on the CXR).
It should be confirmed by culture of a respiratory specimen: protected distal sampling with a threshold of significance ≥ 10 ^ 3 colony forming unit/mL or bronchoalveolar lavage with a threshold of significance ≥ 10 ^ 4 CFU/mL.
Measured: During the 72 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startJan 2015
- Primary completionMay 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279887
- Sponsor's protocol ID
- ECHOVAP
- Acronym
- ECHOVAP
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2017
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dureau P, Bougle A, Melac AT, Ait Hamou N, Arbelot C, Ben Hassen K, Charfeddine A, Deransy R, Arcile G, Rouby JJ, Granger B, Amour J. Colour Doppler ultrasound after major cardiac surgery improves diagnostic accuracy of the pulmonary infection score in acute respiratory failure: A prospective observational study. Eur J Anaesthesiol. 2019 Sep;36(9):676-682. doi: 10.1097/EJA.0000000000001022.
PubMed 31107351
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Lung Ultrasonography for Diagnosis of Pneumonia After Major Cardiac Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT03279887
- Acronym / sponsor ID
- ECHOVAP / ECHOVAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Sep 2017 (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.
Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. This study investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post operative respiratory failure | – | Diagnostic Test: Lung UltrasoundPatients with acute respiratory failure (ARF) less than 72 hours after a major cardiac surgery with cardiopulmonary bypass ARF was defined as one of the following conditions: * If mechanical ventilation, a partial pressure of oxygen/ inspired oxygen fraction ratio (PaO2/FiO2) < 200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation, * If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea> 25/min, upper or intercostal swallowing, abdominal swing ...), pulse oximetry (SpO2) < 90% or PaO2 <60 mmHg despite oxygen therapy ≥ 3 L/min. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory failure after cardiac surgery and hospitalized in the surgical Intensive Care Unit of ICU of Cardiology Institute, Pitié Salpêtrière University Hospital, Paris, France
Key inclusion criteria (4 listed)
- Cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) less than 3 days before
- At least one component suggestive of ARF:
Key exclusion criteria (4 listed)
- Minor patients
- Pregnancy
- Sleep apnea syndrome
- Participation refusal
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 |
|---|---|---|
| Lung Ultrasound | Diagnostic test | Post operative respiratory failure |
Primary outcome
Final diagnosis of pneumonia
Time frame: During the 72 hours following surgery
Pneumonia or excluded pneumonia, was determined by consensus of 3 investigators, after an independent post hoc review of the medical records. Pneumonia diagnosis was based on concordance of clinical and radiological criteria (≥ 2 criteria including fever> 38.5 ° C or T <36 ° C, leukocytosis> 10 ^ 9 / L or leukopenia <4.10 ^ 8 / L, purulent tracheal secretions and the appearance or persistence of an infiltrate on the CXR). It should be confirmed by culture of a respiratory specimen: protected distal sampling with a threshold of significance ≥ 10 ^ 3 colony forming unit/mL or bronchoalveolar lavage with a threshold of significance ≥ 10 ^ 4 CFU/mL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 31107351Dureau P, Bougle A, Melac AT, Ait Hamou N, Arbelot C, Ben Hassen K, Charfeddine A, Deransy R, Arcile G, Rouby JJ, Granger B, Amour J. Colour Doppler ultrasound after major cardiac surgery improves diagnostic accuracy of the pulmonary infection score in acute respiratory failure: A prospective observational study. Eur J Anaesthesiol. 2019 Sep;36(9):676-682. doi: 10.1097/EJA.0000000000001022.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Cardio/Pulm: Respiratory Failure, run by Groupe Hospitalier Pitie-Salpetriere.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Final diagnosis of pneumonia (time frame: During the 72 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279887, which also lists 1 linked publication.
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 13 Sep 2023.