Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients
2 other identifiers
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedFebruary 8, 2021
February 1, 2021
7 months
August 3, 2020
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regional Compliance Variation
The variation of regional compliance, calculated by electrical impedance
From FOB/BAL to 6 hours later
Secondary Outcomes (8)
Regional Resistance Variation
From FOB/BAL to 6 hours later
Regional Compliance and FOB duration
From FOB/BAL to 6 hours later
Regional Compliance and PaO2
From FOB/BAL to 6 hours later
Atelectasis areas and BAL flooded areas
From FOB/BAL to 6 hours later
PaO2 and PaO2/FiO2 ratio
From FOB/BAL to 6 hours later
- +3 more secondary outcomes
Interventions
FOB under full sedation (RASS sedation scale -5) and full paralysis.
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.
Realtime thoracic impedance coupled with ventilation parameters recording.
Multiples Arterial Blood Gas test (ABG) via arterial catheter.
Eligibility Criteria
Intensive Care Unit admitted patients
You may qualify if:
- Mechanically ventilated ICU patients requiring a FOB or FOB + BAL
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasme University Hospital - Intensive Care Unit
Brussels, 1070, Belgium
Related Publications (6)
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.
PMID: 23860341BACKGROUNDKamel 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.
PMID: 31912201BACKGROUNDBauer 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.
PMID: 11396283BACKGROUNDTrouillet 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.
PMID: 2108848BACKGROUNDKlein 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.
PMID: 9885882BACKGROUNDCosta 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.
PMID: 19255741BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Ricottilli, MD
Intensive Care Unit - Erasme University Hospital
- PRINCIPAL INVESTIGATOR
Leda Nobile, MD
Intensive Care Unit - Erasme University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
August 3, 2020
First Posted
August 6, 2020
Study Start
September 1, 2020
Primary Completion
March 30, 2021
Study Completion
April 30, 2021
Last Updated
February 8, 2021
Record last verified: 2021-02