CClinicalTrials.gg
CompletedNCT04348734ECHOPPUpdated Jul 14, 2020

Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

An observational study in Community-Acquired Infections, sponsored by Central Hospital Saint Quentin. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Central Hospital Saint Quentin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
01

Study summary

Parapneumonic pleurisies are a frequent complication of pneumopathies, but therapeutic management is poorly codified. Only the indication of thoracic drainage has benefited from expert recommendations. However, we find in the literature the major importance of early management of infectious pleurisy in order to minimize the sequelae. Pleural ultrasound, sensitive and specific in this pathology could bring us a real interest in terms of diagnostic speed and therefore of care. This study therefore seeks to show that pleural ultrasound can have a major interest in improving the management of patients with parapneumonic pleurisy, by reducing the number of medical treatment failures.

Read the detailed description

This is a prospective, multicentre, non-randomized study evaluating routine care, which includes all patients hospitalized in the departments participating in the study, for pneumonia with or without pleurisy. Patients benefiting from a daily pleural ultrasound for 96 hours, D1 being the day of hospitalization. The therapeutic course of action will depend on the presence or not, and on the type of pleural effusion according to a pre-established algorithm. In case of pleural effusion of type 1, the type of treatment will be left to the appreciation of the clinician (puncture or drainage), in case of pleural effusion of type 2, 3 or 4 the patient benefited from pleural drainage.

Patients included in the study will benefit from a pleural ultrasound on the day of their hospitalization, up to 96 hours after treatment. Ultrasound will then allow us to look for the presence of pleural effusion. In the event of effusion corresponding to a parapneumonic effusion or purulent pleurisy, the conduct to be followed will be defined according to the ultrasound type of effusion. Types 1 will benefit from an evacuating pleural puncture or drainage, depending on the clinician's judgment. Types 2, 3, and 4 will benefit from weeping drainage.

the target population: adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture in the departments participating in the study over the period concerned The main outcome measure is the failure of medical treatment, defined as the need to resort to surgery, with or without peeling, or death secondary to pleurisy. The secondary endpoint is the presence of radiological sequelae at 3 months and 6 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of pleurisy

02

Conditions studied

  • Community-Acquired Infections
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

patients hospitalized for pneumonia

Inclusion criteria

  • adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture.
  • Patients affiliated to social security

Exclusion criteria

Exclusion Criteria:

  • patients with transudative pleurisy,
  • patients with exudative pleurisy in the context of pulmonary neoplasia or tuberculosis,
  • patients with pneumonectomy compartment infections,
  • Patient under guardianship or curatorship,
  • Subjects under 18 years of age,
  • Pregnant women,
  • patients in emergency situations
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testpleural ultrasound

    Patients will benefit from a daily pleural ultrasound for 96 hours, D1 being the day of hospitalization. The therapeutic course of action will depend on the presence or not, and on the type of pleural effusion according to a pre-established algorithm

05

What researchers measure

Primary outcomes

  1. interet de l'échographie pleurale dans les pleurésies parapneumoniques

    Evaluate the failure of medical treatment, defined as the need to resort to surgery, or death secondary to pleuris

    Time frame: 1 year

Secondary outcomes

  1. presence radiological sequelae a pleural effusion at 3 months

    the presence of radiological sequelae at 3 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of a pleural effusion

    Time frame: 3 months

  2. presence radiological sequelae a pleural effusion at 6 months

    the presence of radiological sequelae at 6 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of a pleural effusion

    Time frame: 6 months

06

Study locations

4 sites
  • Chu Amiens
    Amiens, 80000, France
  • CH Pontoise
    Cergy-Pontoise, France
  • CH Creteil
    Créteil, France
  • Saint-Quentin Hospital
    Saint-Quentin, 02100, France
07

References and documents

Publications

  • Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available. PubMed 12806235 ↗
  • Miserocchi G. Physiology and pathophysiology of pleural fluid turnover. Eur Respir J. 1997 Jan;10(1):219-25. doi: 10.1183/09031936.97.10010219. PubMed 9032518 ↗
  • Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available. PubMed 12728147 ↗
  • Hamm H, Light RW. Parapneumonic effusion and empyema. Eur Respir J. 1997 May;10(5):1150-6. doi: 10.1183/09031936.97.10051150. PubMed 9163661 ↗
  • LeMense GP, Strange C, Sahn SA. Empyema thoracis. Therapeutic management and outcome. Chest. 1995 Jun;107(6):1532-7. doi: 10.1378/chest.107.6.1532. PubMed 7781342 ↗
  • Bober K, Swietlinski J. Diagnostic utility of ultrasonography for respiratory distress syndrome in neonates. Med Sci Monit. 2006 Oct;12(10):CR440-6. Epub 2006 Sep 25. PubMed 17006405 ↗
  • Soldati G, Sher S. Bedside lung ultrasound in critical care practice. Minerva Anestesiol. 2009 Sep;75(9):509-17. PubMed 19644435 ↗
  • Ramnath RR, Heller RM, Ben-Ami T, Miller MA, Campbell P, Neblett WW 3rd, Holcomb GW, Hernanz-Schulman M. Implications of early sonographic evaluation of parapneumonic effusions in children with pneumonia. Pediatrics. 1998 Jan;101(1 Pt 1):68-71. doi: 10.1542/peds.101.1.68. PubMed 9417153 ↗
  • Xirouchaki N, Magkanas E, Vaporidi K, Kondili E, Plataki M, Patrianakos A, Akoumianaki E, Georgopoulos D. Lung ultrasound in critically ill patients: comparison with bedside chest radiography. Intensive Care Med. 2011 Sep;37(9):1488-93. doi: 10.1007/s00134-011-2317-y. Epub 2011 Aug 2. PubMed 21809107 ↗
  • Tokuda Y, Matsushima D, Stein GH, Miyagi S. Intrapleural fibrinolytic agents for empyema and complicated parapneumonic effusions: a meta-analysis. Chest. 2006 Mar;129(3):783-90. doi: 10.1378/chest.129.3.783. PubMed 16537882 ↗
  • Stavas J, vanSonnenberg E, Casola G, Wittich GR. Percutaneous drainage of infected and noninfected thoracic fluid collections. J Thorac Imaging. 1987 Jul;2(3):80-7. doi: 10.1097/00005382-198707000-00011. PubMed 3302292 ↗
  • Sahn SA. Management of complicated parapneumonic effusions. Am Rev Respir Dis. 1993 Sep;148(3):813-17. doi: 10.1164/ajrccm/148.3.813. No abstract available. PubMed 8368654 ↗
  • Taryle DA, Potts DE, Sahn SA. The incidence and clinical correlates of parapneumonic effusions in pneumococcal pneumonia. Chest. 1978 Aug;74(2):170-3. doi: 10.1378/chest.74.2.170. No abstract available. PubMed 679746 ↗
  • Pothula V, Krellenstein DJ. Early aggressive surgical management of parapneumonic empyemas. Chest. 1994 Mar;105(3):832-6. doi: 10.1378/chest.105.3.832. PubMed 8131548 ↗
  • Saito T, Kobayashi H, Kitamura S. Ultrasonographic approach to diagnosing chest wall tumors. Chest. 1988 Dec;94(6):1271-5. doi: 10.1378/chest.94.6.1271. PubMed 3056662 ↗
  • Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313. PubMed 26033127 ↗
  • Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8. doi: 10.1378/chest.108.5.1345. PubMed 7587439 ↗

Individual participant data

Plan to share: No — the data will be collected on an electronic Ecrf, a single extraction is planned by the protocol, all the collected data will be analyzed centrally by the study cordernator,no data sharing is planned in the study

08

Registry details

Key details

Study ID
NCT04348734
Lead sponsor
Central Hospital Saint Quentin
Collaborators
Amiens University Hospital
Responsible party
Sponsor
First posted
Apr 16, 2020
Start date
May 4, 2016
Primary completion
May 4, 2020
Completion
May 4, 2020
Last update
Jul 14, 2020

Study contacts

DOUADI Dr Youcef, ch
principal investigator · CH Saint-Quentin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion