Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT04502368
Status:
UNKNOWN
Last Update Posted:
2021-02-08
First Post:
2020-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients
Sponsor:
Erasme University Hospital
Organization:
Study Overview
Official Title:
Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients: Impact on Respiratory Mechanics and Gas Exchange
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P2020/375 | OTHER | Erasme - ULB Ethics Committee | View |