Lung Ultrasonography After Major Cardiac Surgery

Completed

• Conditions: Cardiopulmonary Bypass; Pneumonia; Cardio/Pulm: Respiratory Failure
• Interventions: Diagnostic Test: Lung Ultrasound

• Registration Number: NCT03279887
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-05
• Study Completion: 2016-09
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post operative respiratory failure	Lung Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Final diagnosis of pneumonia	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.