Clinical trial NCT04502368: Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients
Official title: Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients: Impact on Respiratory Mechanics and Gas Exchange
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fiberoptic Bronchoscopy (FOB)
Bronchoalveolar Lavage (BAL)
Respiratory Disease
Keywords: Respiratory Insufficiency
Respiratory Distress Syndrome
Mechanical Ventilation
COVID-19
Fiberoptic Bronchoscopy (FOB)
Bronchoalveolar Lavage (BAL)
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care Unit admitted patients

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).

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.

Primary outcomes:
measure: Regional Compliance Variation
timeFrame: From FOB/BAL to 6 hours later
Secondary outcomes:
measure: Regional Resistance Variation
timeFrame: From FOB/BAL to 6 hours later
measure: Regional Compliance and FOB duration
timeFrame: From FOB/BAL to 6 hours later
measure: Regional Compliance and PaO2
timeFrame: From FOB/BAL to 6 hours later
measure: Atelectasis areas and BAL flooded areas
timeFrame: From FOB/BAL to 6 hours later
measure: PaO2 and PaO2/FiO2 ratio
timeFrame: From FOB/BAL to 6 hours later
measure: PaCO2
timeFrame: From FOB/BAL to 6 hours later
measure: Endotracheal tube size and Fiberscope size
timeFrame: From FOB/BAL to 6 hours later
measure: Hemodynamic variations
timeFrame: From FOB/BAL to 6 hours later
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital - Intensive Care Unit
Study officials:
affiliation: Intensive Care Unit - Erasme University Hospital
name: Francesco Ricottilli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensive Care Unit - Erasme University Hospital
name: Leda Nobile, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
citation: 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.
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. doi: 10.1378/chest.97.4.927.
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. doi: 10.1007/s001340050764.
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.