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Fiberoptic Bronchoscopy (FOB)NCT04502368

Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

An observational study of Fiberoptic Bronchoscopy (FOB) and Bronchoalveolar Lavage (BAL), run by Erasme University Hospital at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fiberoptic Bronchoscopy (FOB), Bronchoalveolar Lavage (BAL) and Electrical Impedance Tomography (EIT)
Type of treatment
Surgery or procedure
How many people
15 participants
Where
1 siteBelgium
Study dates
1 Sep 2020to 30 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Intensive Care Unit admitted patients

Who may be able to join

  • Mechanically ventilated ICU patients requiring a FOB or FOB + BAL

Who cannot join

  • PaO2/FiO2 ratio <100
  • Age < 18 years
  • Pregnancy
  • Unstable angina and recent (less than 1 week) myocardial infarction
  • Uncontrolled cranial hypertension
  • Major hemodynamic instability
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Francesco Ricottilli, MD contact

+32(02)5553344

francesco@ricottilli.eu

Belgium1 site, 1 recruiting

  • Erasme University Hospital - Intensive Care Unit

    Brussels, 1070

    Francesco Ricottilli, MD, +32-2-5553344, francesco@ricottilli.eu

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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).

Being tested
Fiberoptic Bronchoscopy (FOB), Bronchoalveolar Lavage (BAL), Electrical Impedance Tomography (EIT), Arterial Blood Gas test (ABG)
Keywords
Respiratory Insufficiency, Respiratory Distress Syndrome, Mechanical Ventilation, COVID-19, Fiberoptic Bronchoscopy (FOB), Bronchoalveolar Lavage (BAL)
Medical subject headings
Respiration Disorders, Respiratory Insufficiency, Respiratory Distress Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fiberoptic Bronchoscopy (FOB)Procedure or surgery

    FOB under full sedation (RASS sedation scale -5) and full paralysis.

  • Bronchoalveolar Lavage (BAL)Procedure or surgery

    BAL under full sedation (RASS sedation scale -5) and full paralysis. Lavage: NaCl 0,9% 50ml x 3 in lung region targetted according to RX/CT scan.

  • Electrical Impedance Tomography (EIT)Diagnostic test

    Also called PulmoVista® 500 - Draeger

    Realtime thoracic impedance coupled with ventilation parameters recording.

  • Arterial Blood Gas test (ABG)Diagnostic test

    Multiples Arterial Blood Gas test (ABG) via arterial catheter.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regional Compliance Variation

    The variation of regional compliance, calculated by electrical impedance

    Measured: From FOB/BAL to 6 hours later

Secondary outcomes (8)

  1. Regional Resistance Variation

    The variation of regional resistance, calculated by electrical impedance

    Measured: From FOB/BAL to 6 hours later

  2. Regional Compliance and FOB duration

    Relation between regional compliance variation and FOB duration

    Measured: From FOB/BAL to 6 hours later

  3. Regional Compliance and PaO2

    Relation between regional compliance variation and PaO2 variation

    Measured: From FOB/BAL to 6 hours later

  4. Atelectasis areas and BAL flooded areas

    Relation between atelectasis impedance-detected areas and BAL flooded impedance-detected areas

    Measured: From FOB/BAL to 6 hours later

  5. PaO2 and PaO2/FiO2 ratio

    Variation of PaO2 and PaO2/FiO2 ratio post FOB/BAL

    Measured: From FOB/BAL to 6 hours later

  6. PaCO2

    Variation of PaCO2 post FOB/BAL

    Measured: From FOB/BAL to 6 hours later

  7. Endotracheal tube size and Fiberscope size

    Relation between the endotracheal tube/fiberscope size ratio and gas exchanges

    Measured: From FOB/BAL to 6 hours later

  8. Hemodynamic variations

    Heart rate (HR), Blood Pressure (BP)

    Measured: From FOB/BAL to 6 hours later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start1 Sep 2020
  3. Primary completion30 Mar 2021 (estimated)
  4. Study completion30 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502368
Sponsor's protocol ID
SRB2020-289
Other IDs
P2020/375
Status last verified
Feb 2021
First submitted
3 Aug 2020
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.

    PubMed 23860341

  • Kamel T, Helms J, Janssen-Langenstein R, Kouatchet A, Guillon A, Bourenne J, Contou D, Guervilly C, Coudroy R, Hoppe MA, Lascarrou JB, Quenot JP, Colin G, Meng P, Roustan J, Cracco C, Nay MA, Boulain T; Clinical Research in Intensive Care Sepsis Group (CRICS-TRIGGERSEP). Benefit-to-risk balance of bronchoalveolar lavage in the critically ill. A prospective, multicenter cohort study. Intensive Care Med. 2020 Mar;46(3):463-474. doi: 10.1007/s00134-019-05896-4. Epub 2020 Jan 7.

    PubMed 31912201

  • Bauer TT, Torres A, Ewig S, Hernandez C, Sanchez-Nieto JM, Xaubet A, Agusti C, Rodriguez-Roisin R. Effects of bronchoalveolar lavage volume on arterial oxygenation in mechanically ventilated patients with pneumonia. Intensive Care Med. 2001 Feb;27(2):384-93. doi: 10.1007/s001340000781.

    PubMed 11396283

  • Trouillet JL, Guiguet M, Gibert C, Fagon JY, Dreyfuss D, Blanchet F, Chastre J. Fiberoptic bronchoscopy in ventilated patients. Evaluation of cardiopulmonary risk under midazolam sedation. Chest. 1990 Apr;97(4):927-33. doi: 10.1378/chest.97.4.927.

    PubMed 2108848

  • Klein U, Karzai W, Zimmermann P, Hannemann U, Koschel U, Brunner JX, Remde H. Changes in pulmonary mechanics after fiberoptic bronchoalveolar lavage in mechanically ventilated patients. Intensive Care Med. 1998 Dec;24(12):1289-93. doi: 10.1007/s001340050764.

    PubMed 9885882

  • Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.

    PubMed 19255741

Questions about this trial

What is this clinical trial studying?

An observational study of Fiberoptic Bronchoscopy (FOB) and Bronchoalveolar Lavage (BAL), run by Erasme University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francesco Ricottilli, MD (+32(02)5553344, francesco@ricottilli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional Compliance Variation (time frame: From FOB/BAL to 6 hours later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502368, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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