Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

NCT ID: NCT04502368

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-04-30

Brief 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. 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.

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).

Conditions

Fiberoptic Bronchoscopy (FOB); Bronchoalveolar Lavage (BAL); Respiratory Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Fiberoptic Bronchoscopy (FOB)

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

Intervention Type: PROCEDURE

Bronchoalveolar Lavage (BAL)

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.

Intervention Type: PROCEDURE

Electrical Impedance Tomography (EIT)

Realtime thoracic impedance coupled with ventilation parameters recording.

Intervention Type: DIAGNOSTIC_TEST

Arterial Blood Gas test (ABG)

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PulmoVista® 500 - Draeger

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Francesco Ricottilli, MD

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Ricottilli, MD

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit - Erasme University Hospital

Leda Nobile, MD

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit - Erasme University Hospital

Locations

Erasme University Hospital - Intensive Care Unit

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Francesco Ricottilli, MD

Role: CONTACT

francesco@ricottilli.eu

+32(02)5553344

Facility Contacts

Francesco Ricottilli, MD

Role: primary

francesco@ricottilli.eu

+32-2-5553344

References

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.

Reference Type: BACKGROUND

PMID: 23860341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31912201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11396283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2108848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9885882 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19255741 (View on PubMed)

Other Identifiers

P2020/375

Identifier Type: OTHER

Identifier Source: secondary_id

SRB2020-289

Identifier Type: -

Identifier Source: org_study_id