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Completed

NCT Number: NCT03279887

Lung Ultrasonography After Major Cardiac Surgery

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.

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Key information

Conditions

Pneumonia Cardio/Pulm: Respiratory Failure Cardiopulmonary Bypass Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lung Ultrasound

Diagnostic Test

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Usefulness of Lung Ultrasonography for Diagnosis of Pneumonia After Major Cardiac Surgery: a Pilot Study

Acronym: ECHOVAP

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 12, 2017
Registry last updated
Sep 13, 2023

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.

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