Lung Ultrasonography After Major Cardiac Surgery

Pneumonia Clinical Trial

— ECHOVAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279887
• Other study ID #: ECHOVAP
• Status: Completed
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This study investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardio/Pulm: Respiratory Failure
• Cardiopulmonary Bypass
• Pneumonia
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• Lung Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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