Lung Ultrasonography After Major Cardiac Surgery

NCT ID: NCT03279887

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Pneumonia; Cardio/Pulm: Respiratory Failure; Cardiopulmonary Bypass

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Lung Ultrasound

Intervention Type: DIAGNOSTIC_TEST

Interventions

Lung Ultrasound

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: lead

Responsible Party

Adrien Bouglé

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31107351 (View on PubMed)

Other Identifiers

ECHOVAP

Identifier Type: -

Identifier Source: org_study_id