Clinical Trials Directory

Trials / Unknown

UnknownNCT04502368

Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

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

Status
Unknown
Phase
Study type
Observational
Enrollment
15 (estimated)
Sponsor
Erasme University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREFiberoptic Bronchoscopy (FOB)FOB under full sedation (RASS sedation scale -5) and full paralysis.
PROCEDUREBronchoalveolar 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_TESTElectrical Impedance Tomography (EIT)Realtime thoracic impedance coupled with ventilation parameters recording.
DIAGNOSTIC_TESTArterial Blood Gas test (ABG)Multiples Arterial Blood Gas test (ABG) via arterial catheter.

Timeline

Start date
2020-09-01
Primary completion
2021-03-30
Completion
2021-04-30
First posted
2020-08-06
Last updated
2021-02-08

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04502368. Inclusion in this directory is not an endorsement.