Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

• Conditions: Fiberoptic Bronchoscopy (FOB); Bronchoalveolar Lavage (BAL); Respiratory Disease

• Registration Number: NCT04502368
• Lead Sponsor: Erasme University Hospital

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).

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Study Start: 2020-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regional Compliance Variation	From FOB/BAL to 6 hours later	The variation of regional compliance, calculated by electrical impedance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasme University Hospital - Intensive Care Unit; 🇧🇪 Brussels, Belgium