Bronchoscopy in Lower Respiratory Tract Infection in Respiratory Intensive Care Unit

NCT03846401 | Unknown

• 1 other identifier: Bronchoscopy in LRTI
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Antimicrobial resistance pattern

  isolated organism and drug sensitivity test by Automated Vitek2 Compact(BioMérieux, France).

  1 year

Secondary Outcomes (2)

• pathogen identification

  1 year

• recovering an array of microorganisms

  1 year

Interventions

fiberoptic bronchoscopy DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Mahendra M, Jayaraj BS, Lokesh KS, Chaya SK, Veerapaneni VV, Limaye S, Dhar R, Swarnakar R, Ambalkar S, Mahesh PA. Antibiotic Prescription, Organisms and its Resistance Pattern in Patients Admitted to Respiratory ICU with Respiratory Infection in Mysuru. Indian J Crit Care Med. 2018 Apr;22(4):223-230. doi: 10.4103/ijccm.IJCCM_409_17.

  PMID: 29743760 BACKGROUND

• Ahmed SM, Jakribettu RP, Meletath SK, B A, Vpa S. Lower Respiratory Tract Infections (LTRIs): An Insight into the Prevalence and the Antibiogram of the Gram Negative, Respiratory, Bacterial Agents. J Clin Diagn Res. 2013 Feb;7(2):253-6. doi: 10.7860/JCDR/2013/5308.2740. Epub 2013 Jan 10.

  PMID: 23543819 BACKGROUND

• Jaffal K, Six S, Zerimech F, Nseir S. Relationship between hyperoxemia and ventilator associated pneumonia. Ann Transl Med. 2017 Nov;5(22):453. doi: 10.21037/atm.2017.10.15.

  PMID: 29264370 BACKGROUND

• Smeijsters KMG, Bijkerk RM, Daniels JMA, van de Ven PM, Girbes ARJ, Heunks LMA, Spijkstra JJ, Tuinman PR. Effect of Bronchoscopy on Gas Exchange and Respiratory Mechanics in Critically Ill Patients With Atelectasis: An Observational Cohort Study. Front Med (Lausanne). 2018 Nov 13;5:301. doi: 10.3389/fmed.2018.00301. eCollection 2018.

  PMID: 30483505 BACKGROUND

• Qiao Z, Yu J, Yu K, Zhang M. The benefit of daily sputum suction via bronchoscopy in patients of chronic obstructive pulmonary disease with ventilators: A randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(31):e11631. doi: 10.1097/MD.0000000000011631.

  PMID: 30075543 BACKGROUND

• Chung SM, Choi JW, Lee YS, Choi JH, Oh JY, Min KH, Hur GY, Lee SY, Shim JJ, Kang KH. Clinical Effectiveness of High-Flow Nasal Cannula in Hypoxaemic Patients during Bronchoscopic Procedures. Tuberc Respir Dis (Seoul). 2019 Jan;82(1):81-85. doi: 10.4046/trd.2017.0104. Epub 2018 Jun 19.

  PMID: 29926544 BACKGROUND

Study Officials

• Maha K. Ghanem, Prof

  Assiut University

  STUDY CHAIR

• Hoda A. Makhlouf, Prof

  Assiut University

  STUDY DIRECTOR

• Ali A. Hasan, ass. prof.

  Assiut University

  STUDY DIRECTOR

• Asmaa O. Ahmed, ass. prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Yara Y. Omar, MD

CONTACT

+201227480640; yara_omar90@live.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chest Specialist in Assiut University Hospital

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 19, 2019
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 11, 2020

Record last verified: 2020-05