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Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia

15 avril 2020 mis à jour par: David Grant U.S. Air Force Medical Center

Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia: Who Needs a Chest X-Ray?

This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005 will be included as positive cases. Controls will be randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Once patients are appropriately identified as control or cases, outpatient charts will be reviewed to gather data on six clinical indicators. Sensitivities and specificities will be calculated for each clinical indicator, to determine which patients require chest radiographs in the setting of suspected community acquired pneumonia (CAP)

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

This was a retrospective study designed to evaluate the efficacy of six clinical indicators to predict the presence of pulmonary infiltrates on chest radiography.

The study population will include a convenience sample of David Grant Air Force Medical Center patients that meet study criteria. Adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 will be enrolled as positive cases. There will be an equal number of controls with acute respiratory symptoms but negative radiographs. Controls will be matched by age and date of radiograph. Patients/Cases with suspected hospital-acquired (positive radiographs within 10 days of hospital discharge) or aspiration pneumonia will be excluded

Six clinical indicators were selected based on the cumulative results of seminal studies that included: cough, sputum production, temperature, heart rate, respiratory rate, and findings on physical examination. Abnormal vital signs were defined as temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per minute. Positive physical examination findings consisted of the presence of crackles, decreased breath sounds, dullness to percussion, egophony, or rhonchi

Outpatient emergency room physicians will record data regarding the clinical indicators prior to obtaining chest radiographs; thus, they will be blinded to the radiographic findings. All chests radiographs will be subsequently interpreted by a board-certified radiologist blinded to the clinical findings. Positive radiographic findings will be defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" will be considered positive cases. For each positive case, a single control was randomly selected from a list of eligible controls with acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case.

Once patients are appropriately identified as cases or controls, outpatient charts will be reviewed to gather data regarding the six clinical indicators will be entered into the study database for analysis upon completion of the study. The sample size necessary to predict the proportion of patients with CAP who have all six clinical indicators was calculated as 385, assuming 95% confidence level and a 5% margin of error. Sample size estimates assume a random sample, which is not possible for us to obtain in this study; any conclusion that we draw will thus e cautiously interpreted. We will conduct this study for a minimum of one year with the intent to continue until a sample size of at least 385 is obtained. Upon completion of the study sensitivities and specificities and accompanying 95% confidence intervals for clinical indicators will be made to determine which combination of indicators best predicts the presence of pulmonary infiltrates in patients with CAP. Further analysis will be made within specific age groups (e.g., 18-40, 41-60, older than 60) and amongst those patients with pre-existing pulmonary disease

Type d'étude

Observationnel

Inscription (Réel)

350

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • Travis Air Force Base, California, États-Unis, 94535
        • David Grant USAF Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

All adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 were enrolled as positive cases with an equal number of controls with acute respiratory symptoms but negative radiographs; controls were matched by age and date of radiograph

La description

Inclusion Criteria:

  • 18 years of age or older
  • acute respiratory symptoms
  • positive chest radiographs
  • patients from outpatient clinics and the emergency department

Exclusion Criteria:

  • under the age of 18
  • suspected hospital-acquired pneumonia (positive radiographs within 10 days of hospital discharge)
  • suspected aspiration pneumonia

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Positive cases
Positive radiographic findings were defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" were considered positive cases
Control
Acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: William T. O'Brien, D.O., David Grant USAF Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2004

Achèvement primaire (Réel)

1 avril 2005

Achèvement de l'étude (Réel)

1 avril 2005

Dates d'inscription aux études

Première soumission

1 juillet 2005

Première soumission répondant aux critères de contrôle qualité

1 juillet 2005

Première publication (Estimation)

12 juillet 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 avril 2020

Dernière vérification

1 avril 2020

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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