Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P2020/375 | Other Identifier | Erasme - ULB Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiberoptic Bronchoscopy (FOB) | Procedure | FOB under full sedation (RASS sedation scale -5) and full paralysis. | ||
| Bronchoalveolar Lavage (BAL) | Procedure | 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 | Realtime thoracic impedance coupled with ventilation parameters recording. |
| |
| Arterial Blood Gas test (ABG) | Diagnostic Test | Multiples Arterial Blood Gas test (ABG) via arterial catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Compliance Variation | The variation of regional compliance, calculated by electrical impedance | From FOB/BAL to 6 hours later |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Resistance Variation | The variation of regional resistance, calculated by electrical impedance | From FOB/BAL to 6 hours later |
| Regional Compliance and FOB duration | Relation between regional compliance variation and FOB duration |
Not provided
Inclusion Criteria:
Mechanically ventilated ICU patients requiring a FOB or FOB + BAL
Exclusion Criteria:
Patients who had undergone several bronchoscopy procedures could not be included twice.
Not provided
Not provided
Not provided
Intensive Care Unit admitted patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Ricottilli, MD | Contact | +32(02)5553344 | francesco@ricottilli.eu |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Ricottilli, MD | Intensive Care Unit - Erasme University Hospital | Principal Investigator |
| Leda Nobile, MD | Intensive Care Unit - Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme University Hospital - Intensive Care Unit | Recruiting | Brussels | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23860341 | Background | 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. | |
| 31912201 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From FOB/BAL to 6 hours later |
| Regional Compliance and PaO2 | Relation between regional compliance variation and PaO2 variation | From FOB/BAL to 6 hours later |
| 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 |
| PaO2 and PaO2/FiO2 ratio | Variation of PaO2 and PaO2/FiO2 ratio post FOB/BAL | From FOB/BAL to 6 hours later |
| PaCO2 | Variation of PaCO2 post FOB/BAL | From FOB/BAL to 6 hours later |
| Endotracheal tube size and Fiberscope size | Relation between the endotracheal tube/fiberscope size ratio and gas exchanges | From FOB/BAL to 6 hours later |
| Hemodynamic variations | Heart rate (HR), Blood Pressure (BP) | From FOB/BAL to 6 hours later |
| Background |
| 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. |
| 11396283 | Background | 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. |
| 2108848 | Background | 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. |
| 9885882 | Background | 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. |
| 19255741 | Background | 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. |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012131 | Respiratory Insufficiency |
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
Not provided
Not provided