Lung Ultrasonography After Major Cardiac Surgery (ECHOVAP)

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Cardiopulmonary Bypass; Cardio/Pulm: Respiratory Failure
• Intervention / Treatment: Diagnostic test: Lung Ultrasound

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Lung Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the 72 hours following surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Pneumonia
• Other Study ID Numbers: ECHOVAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No