Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502368
• Other study ID #: SRB2020-289
• Secondary ID: P2020/375
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2021
• Source: Erasme University Hospital
• Contact: Francesco Ricottilli, MD
• Phone: +32(02)5553344
• Email: francesco[@]ricottilli.eu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchoalveolar Lavage (BAL)
• Fiberoptic Bronchoscopy (FOB)
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Procedure:
• Fiberoptic Bronchoscopy (FOB)
FOB under full sedation (RASS sedation scale -5) and full paralysis.
• 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.

Diagnostic Test:
• Electrical Impedance Tomography (EIT)
Realtime thoracic impedance coupled with ventilation parameters recording.
• Arterial Blood Gas test (ABG)
Multiples Arterial Blood Gas test (ABG) via arterial catheter.

Locations

Country	Name	City	State
Belgium	Erasme University Hospital - Intensive Care Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Bauer TT, Torres A, Ewig S, Hernández C, Sanchez-Nieto JM, Xaubet A, Agustí 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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