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Bronchoscopy in Lower Respiratory Tract Infection in Respiratory Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03846401
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yara Yasser Omar, Assiut University

Brief Summary:
Evaluate the diagnostic and therapeutic role of fiberoptic bronchoscopy in management of patients with lower respiratory tract infection in Respiratory Intensive Care Unit of Assiut University Hospital

Condition or disease Intervention/treatment
Lower Respiratory Tract Infection Device: fiberoptic bronchoscopy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Role of Fiberoptic Bronchoscopy in Patients With Lower Respiratory Tract Infection in Respiratory Intensive Care Unit of Assiut University Hospital
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Intervention Details:
  • Device: fiberoptic bronchoscopy

    Will be performed according to British Thoracic Society guidelines 2013.

    -Microbiological methods The specimen (tracheal aspirate & BAL) will be collected under aseptic conditions in a sterile container and immediately sent to the laboratory for microbiological analyses.

    Samples will be apply for:

    1. Direct smear by Gram stain and ZeihlNelseen stain
    2. Samples culturedinBact/alert bottle(BioMérieux, France).
    3. Isolation of causative organism from positive cases by:

      Subculture on MacConkey , blood , chocolate agar , Sabouroud`s agar and Lowenstien Jensen media.

    4. Identification of isolated organism and drug sensitivity test by Automated Vitek2 Compact(BioMérieux, France).
    5. Multiplex PCR for detection of Respiratory viruses in lower respiratory tract


Primary Outcome Measures :
  1. Antimicrobial resistance pattern [ Time Frame: 1 year ]
    isolated organism and drug sensitivity test by Automated Vitek2 Compact(BioMérieux, France).


Secondary Outcome Measures :
  1. pathogen identification [ Time Frame: 1 year ]
    by Multiplex PCR

  2. recovering an array of microorganisms [ Time Frame: 1 year ]
    by BACT/ALERT® Culture Media



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with lower respiratory tract infection in the Respiratory Intensive Care Unit (R.I.C.U.), Department of Chest Diseases and Tuberculosis, Assiut University Hospital
Criteria

Inclusion Criteria:

  • Adult patients > 18 years old in R.I.C.U who are on mechanical ventilator or high flow nasal cannula oxygen with lower respiratory tract infection or who show atelectasis on CXR in which the standard therapy failed will be included in this study

Exclusion Criteria:

  • Severely hypoxemic patients under high-FiO2 support and/or high PEEP, if the patient is unable to keep oxygen saturation >90% with an FiO2 of 0.9-1.0 or a PaO2/FiO2 ratio of <100, Severe acidosis, Ph<7,2
  • Presence of pneumothorax
  • Active bronchospasm.
  • Patients with acute coronary problems, such as acute arrhythmia, acute myocardial infarction or ongoing hemodynamic instability, under vasoactive therapy.
  • patients with known intracranial hypertension
  • patients have coagulation abnormalities, such as thrombocytopenia or elevated prothrombin time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846401


Contacts
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Contact: Yara Y. Omar, MD +201227480640 yara_omar90@live.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Maha K. Ghanem, Prof Assiut University
Study Director: Hoda A. Makhlouf, Prof Assiut University
Study Director: Ali A. Hasan, ass. prof. Assiut University
Study Director: Asmaa O. Ahmed, ass. prof Assiut University

Publications:

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Responsible Party: Yara Yasser Omar, Chest Specialist in Assiut University Hospital, Assiut University
ClinicalTrials.gov Identifier: NCT03846401     History of Changes
Other Study ID Numbers: Bronchoscopy in LRTI
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases