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Lung Ultrasonography After Major Cardiac Surgery (ECHOVAP)

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ClinicalTrials.gov Identifier: NCT03279887
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere

September 4, 2017
September 12, 2017
September 12, 2017
January 2015
May 2015   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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Lung Ultrasonography After Major Cardiac Surgery
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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
  • Pneumonia
  • Cardio/Pulm: Respiratory Failure
  • Cardiopulmonary Bypass
Diagnostic Test: Lung Ultrasound
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.
Intervention: Diagnostic Test: Lung Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
Same as current
September 2016
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Minor patients
  • Pregnancy
  • Sleep apnea syndrome
  • Participation refusal
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03279887
ECHOVAP
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere
Groupe Hospitalier Pitie-Salpetriere
Not Provided
Not Provided
Groupe Hospitalier Pitie-Salpetriere
September 2017