Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia

August 24, 2025 updated by: Gehad Mohamed Mohsen Mahmoud, Benha University

The Clinical Effect of Fiberoptic Bronchoscopy in Management of Adult Patients With Severe Ventilator-associated Pneumonia; a Randomized Controlled Trial

This randomized controlled trial evaluated the clinical effect of fiberoptic bronchoscopy in the management of adult patients with severe ventilator-associated pneumonia (VAP). A total of 100 patients admitted to the Critical Care Department at Benha University Hospitals were enrolled and randomly assigned in equal numbers to two groups. The control group received standard therapy, including culture-guided antibiotics, lavage, and aspiration. The intervention group received the same treatment plus fiberoptic bronchoscopy for secretion clearance, lavage, and culture-directed antibiotic therapy.

The primary outcome was the overall effective treatment rate, defined as the proportion of patients with significant or partial clinical improvement. Secondary outcomes included recovery time, length of intensive care unit stay, respiratory mechanics, inflammatory markers (C-reactive protein and procalcitonin), recurrence of pulmonary infection, and 28-day mortality.

The study demonstrated whether the addition of fiberoptic bronchoscopy to conventional treatment improved clinical outcomes in patients with severe ventilator-associated pneumonia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-65 years
  • Patients of both sexes
  • Patients requiring mechanical ventilation
  • Development of pneumonia ≥ 48 hours after endotracheal intubation or ≥ 48 hours after extubation
  • Diagnosis of severe ventilator-associated pneumonia defined by a Modified Clinical Pulmonary Infection Score (CPIS) > 6

Exclusion Criteria:

  • Refusal to participate
  • Presence of lung shadows prior to mechanical ventilation
  • Severe bleeding disorders or immune system diseases
  • Severe hemodynamic instability
  • Recent myocardial infarction or unstable arrhythmia
  • Tracheal stenosis or upper airway mass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Participants received standard therapy for severe ventilator-associated pneumonia, which included culture-guided antibiotics, routine drug therapy, tracheal lavage, and aspiration. Sputum samples were collected for bacterial culture and sensitivity testing to guide antibiotic selection.
Other: Other (Conventional Therapy)
Participants received standard therapy including culture-guided antibiotics, tracheal lavage, and aspiration. Sputum samples were collected from the lower trachea for culture and sensitivity testing to guide antibiotic selection.
Experimental: Fiberoptic Bronchoscopy Group
Participants received the same standard therapy as the control group plus fiberoptic bronchoscopy. The bronchoscope was inserted via the endotracheal tube to clear secretions, obtain samples for culture, and perform bronchoscopic alveolar lavage. Lavage was performed once daily for one week using sterile sodium chloride solution with ambroxol hydrochloride, followed by antibiotic administration. Cultures were used to guide therapy.
Procedure: Fiberoptic Bronchoscopy
Participants underwent fiberoptic bronchoscopy through the endotracheal tube for secretion clearance, sample collection, and alveolar lavage once daily for one week. Sterile sodium chloride solution with ambroxol hydrochloride was instilled, and antibiotics were administered immediately after lavage. Samples were cultured to guide antibiotic therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Effective Treatment Rate
Time Frame: Postoperatively (within 28 days of VAP diagnosis).
Proportion of patients achieving significant or partial clinical improvement based on resolution of symptoms, normalization of temperature and laboratory markers, negative sputum cultures, and radiologic improvement.
Postoperatively (within 28 days of VAP diagnosis).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery Time
Time Frame: Up to 28 days from diagnosis.
Duration from diagnosis of ventilator-associated pneumonia (VAP) until Modified Clinical Pulmonary Infection Score (CPIS) decreased to below 6.
Up to 28 days from diagnosis.
Length of intensive care unit (ICU) stay
Time Frame: From intensive care unit (ICU) admission until discharge (maximum 28 days).
Total number of days spent in the intensive care unit during the hospital admission.
From intensive care unit (ICU) admission until discharge (maximum 28 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD: 8-11-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (de-identified) that underlie the results reported in this trial will be made available to qualified researchers upon reasonable request for the purpose of meta-analyses and further research on ventilator-associated pneumonia management.

IPD Sharing Time Frame

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the main study results and for up to 5 years thereafter.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal will be granted access after review and approval by the principal investigator and the Research Ethics Committee of Benha Faculty of Medicine. Data will be shared through secure data transfer agreements to ensure confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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