NCT03279887

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 4, 2017

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Lung UltrasoundDIAGNOSTIC_TEST
Post operative respiratory failure

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Minor patients
  • Pregnancy
  • Sleep apnea syndrome
  • Participation refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 12, 2017

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

September 1, 2016

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share