Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

February 5, 2021 updated by: Francesco Ricottilli, MD, Erasme University Hospital

Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients: Impact on Respiratory Mechanics and Gas Exchange

Fiberoptic bronchoscopy (FOB) is widely used as a diagnostic or therapeutic procedure in intensive care units. Patients with ARDS or COVID-19 disease often undergoes to these procedures. However, intensive care patients might suffer from serious side effects such as prolonged oxygen desaturation and adverse change in lung compliance and resistance. This study aims to evaluate these changes and determine their impact on patient stability.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fiberoptic bronchoscopy (FOB) is widely used in intensive care units as a diagnostic or therapeutic procedure. FOB in respiratory failure patients supported by mechanical ventilation may worsen hypoxemia and hypercapnia, therefore FOB requires careful consideration in this patient population. The generally accepted indications for FOB in ventilated patients are removal of retained secretions, resolution of atelectasis and evaluation of hemoptysis. A diagnostic indication is the bronchoalveolar lavage (BAL), to sample the lower respiratory tract without contamination. Studies of FOB performed in mechanically ventilated patients suggest an acceptable safety profile, except for the occurrence of hypoxemia as the main adverse event. Bronchoalveolar Lavage (BAL) in normal volunteers is reported to be safe and does not lead to measurable changes in pulmonary function parameters. However, in intensive care patients may suffer from serious side effects such as prolonged oxygen desaturation. Moreover, reductions in arterial oxygen tension (PaO2) have been reported to persist in some patients for 4 h and more after the procedure. Authors reported the BAL procedure is associated to a worsening of PaO2/FiO2 ratio, in several ARDS patients the drop in PaO2 was higher than 30%. Moreover a physiological study in patients undergoing FOB and BAL showed adverse change in lung compliance and resistance.

The purpose of this prospective study is to determine the alterations in respiratory mechanics (regional compliance and resistance) and gas exchange induced by FOB and BAL up to 6 hours after the procedure. The lung regional ventilation evaluation will be made by electrical impedance tomography (EIT).

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

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

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • Erasme University Hospital - Intensive Care Unit
        • Contact:

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intensive Care Unit admitted patients

Description

Inclusion Criteria:

Mechanically ventilated ICU patients requiring a FOB or FOB + BAL

Exclusion Criteria:

  • PaO2/FiO2 ratio <100
  • Age < 18 years
  • Pregnancy
  • Unstable angina and recent (less than 1 week) myocardial infarction
  • Uncontrolled cranial hypertension
  • Major hemodynamic instability
  • Any previous lung surgery (except for lung transplantation)
  • Obesity (BMI > 50)
  • Chest circumference > 150 cm
  • Electronic implanted device (pacemaker, neurostimulator, etc.)

Patients who had undergone several bronchoscopy procedures could not be included twice.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Compliance Variation
Time Frame: From FOB/BAL to 6 hours later
The variation of regional compliance, calculated by electrical impedance
From FOB/BAL to 6 hours later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Resistance Variation
Time Frame: From FOB/BAL to 6 hours later
The variation of regional resistance, calculated by electrical impedance
From FOB/BAL to 6 hours later
Regional Compliance and FOB duration
Time Frame: From FOB/BAL to 6 hours later
Relation between regional compliance variation and FOB duration
From FOB/BAL to 6 hours later
Regional Compliance and PaO2
Time Frame: From FOB/BAL to 6 hours later
Relation between regional compliance variation and PaO2 variation
From FOB/BAL to 6 hours later
Atelectasis areas and BAL flooded areas
Time Frame: From FOB/BAL to 6 hours later
Relation between atelectasis impedance-detected areas and BAL flooded impedance-detected areas
From FOB/BAL to 6 hours later
PaO2 and PaO2/FiO2 ratio
Time Frame: From FOB/BAL to 6 hours later
Variation of PaO2 and PaO2/FiO2 ratio post FOB/BAL
From FOB/BAL to 6 hours later
PaCO2
Time Frame: From FOB/BAL to 6 hours later
Variation of PaCO2 post FOB/BAL
From FOB/BAL to 6 hours later
Endotracheal tube size and Fiberscope size
Time Frame: From FOB/BAL to 6 hours later
Relation between the endotracheal tube/fiberscope size ratio and gas exchanges
From FOB/BAL to 6 hours later
Hemodynamic variations
Time Frame: From FOB/BAL to 6 hours later
Heart rate (HR), Blood Pressure (BP)
From FOB/BAL to 6 hours later

Collaborators and Investigators

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

Sponsor

Erasme University Hospital

Investigators

  • Principal Investigator: Francesco Ricottilli, MD, Intensive Care Unit - Erasme University Hospital
  • Principal Investigator: Leda Nobile, MD, Intensive Care Unit - Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2020

Primary Completion (Anticipated)

March 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRB2020-289
  • P2020/375 (Other Identifier: Erasme - ULB Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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