Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients
Primary Purpose
Acute Respiratory Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Recruiting Maneuver
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Failure focused on measuring Secretions, Bronchoscopy, Lung Ultrasound, Electrical Impedance Tomography
Eligibility Criteria
Inclusion Criteria:
- invasive mechanical ventilation
- need for flexible bronchoscopy to remove secretion plug from the airway
Exclusion Criteria:
- hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion);
- need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min;
- life-threatening arrhythmias or electrocardiographic signs of ischemia;
- contraindications to placement of Electrical Impedance Tomography belt, Lung UltraSound or application of a Recruiting Maneuver (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week);
- inclusion in other research protocols.
Sites / Locations
- AOU Mater Domini
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Flexible Bronchoscopy without Recruiting Maneuver
Flexible Bronchoscopy with Recruiting Maneuver
Arm Description
At the end of the bronchoscopy, no further interventions or ventilator maneuvers will be done.
At the end of the bronchoscopy, a recruiting maneuver will be applied to the patients. Recruiting Maneuver consists in the application of an airway pressure of 30 cmH2O for a period of 30 seconds.
Outcomes
Primary Outcome Measures
Lung Aeration through EIT
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Lung Aeration through Lung Ultrasound
Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)
Secondary Outcome Measures
Arterial Blood Gases
Arterial Blood Gases will be assessed through an arterial blood sample
Arterial Blood Gases
Arterial Blood Gases will be assessed through an arterial blood sample
Lung Aeration through EIT
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Lung Aeration through Lung Ultrasound
Improvement of lung aeration will be assess with Lung Ultrasound Score , as compared to baseline (before the bronchoscopy)
Full Information
NCT ID
NCT05200494
First Posted
January 6, 2022
Last Updated
January 6, 2022
Sponsor
University Magna Graecia
1. Study Identification
Unique Protocol Identification Number
NCT05200494
Brief Title
Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients
Official Title
Assessment of Lung Aeretion After Flexible Bronchoscopy for Secretion Removal in Intubated Critically Ill Patients Receiving or Not a Recruiting Maneuver Soon After the Procedure: an Observational Physiological Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients suffering from acute respiratory failure, ineffective cough and the consequent retention of secretions are common clinical problems, which often lead to the need for tracheostomy for the sole purpose of aspiration of secretions from the airways.
Mechanically ventilated critically ill patients often have impaired mucus transport which is associated with secretion retention and subsequent development of pneumonia. The accumulation of tracheobronchial secretions in ventilated patients in ICU is due not only to an increased production, but also to a decreased clearance. In the event that secretions occlude a bronchus, an atelectasis of the lung parenchyma is created downstream. Therefore, it is often necessary to perform a flexible bronchoscopy (FOB) to proceed with the removal of the secretion plug. After its removal, the lung is supposed to be reventilated and recruited.
In intubated ICU patients, the application of a recruiting maneuver (RM) is commonly used to reopen the collapsed lung in patients with Acute Respiratory Distress Syndrome or in case of atelectasis in other clinical conditions. However, no studies have so far investigated the role of the application of a RM after a FOB performed to remove a secretion plug in intubated ICU patients.
This observational and physiological study aims to assess if the application of a RM would modify the lung aeration soon after an FOB to remove secretion plug (first outcome). Moreover, the study aims to assess if EIT could be an additional bedside imaging tool to monitor modifications of lung ventilation and aeration during and after a flexible bronchoscopy, as compared with both chest-X-ray and lung ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Secretions, Bronchoscopy, Lung Ultrasound, Electrical Impedance Tomography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive or not a Recruiting Maneuver (RM) at the end of the Flexible Bronchoscopy. RM will be performed by the application to the airways of 30 cmH2O positive pressure for 30 seconds.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be masked since he/she will be not present at the end of the procedure, when the intervention (Recruiting Maneuver) will be applied or not.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flexible Bronchoscopy without Recruiting Maneuver
Arm Type
No Intervention
Arm Description
At the end of the bronchoscopy, no further interventions or ventilator maneuvers will be done.
Arm Title
Flexible Bronchoscopy with Recruiting Maneuver
Arm Type
Experimental
Arm Description
At the end of the bronchoscopy, a recruiting maneuver will be applied to the patients. Recruiting Maneuver consists in the application of an airway pressure of 30 cmH2O for a period of 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
Recruiting Maneuver
Intervention Description
Airway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy
Primary Outcome Measure Information:
Title
Lung Aeration through EIT
Description
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Time Frame
One hour after the end of the bronchoscopy
Title
Lung Aeration through Lung Ultrasound
Description
Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)
Time Frame
One hour after the end of the bronchoscopy
Secondary Outcome Measure Information:
Title
Arterial Blood Gases
Description
Arterial Blood Gases will be assessed through an arterial blood sample
Time Frame
Soon after the end of the bronchoscopy
Title
Arterial Blood Gases
Description
Arterial Blood Gases will be assessed through an arterial blood sample
Time Frame
One hour after the end of the bronchoscopy
Title
Lung Aeration through EIT
Description
Improvement of lung aeration will be assess with End Expiratory Lung Impedance through Electrical Impedance Tomography, as compared to baseline (before the bronchoscopy)
Time Frame
Soon after the end of the bronchoscopy
Title
Lung Aeration through Lung Ultrasound
Description
Improvement of lung aeration will be assess with Lung Ultrasound Score , as compared to baseline (before the bronchoscopy)
Time Frame
Soon after the end of the bronchoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
invasive mechanical ventilation
need for flexible bronchoscopy to remove secretion plug from the airway
Exclusion Criteria:
hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion);
need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min;
life-threatening arrhythmias or electrocardiographic signs of ischemia;
contraindications to placement of Electrical Impedance Tomography belt, Lung UltraSound or application of a Recruiting Maneuver (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week);
inclusion in other research protocols.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Longhini, MD
Phone
+393475395967
Email
longhini.federico@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Longhini, MD
Organizational Affiliation
Magna Graecia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Mater Domini
City
Catanzaro
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
IPD Sharing Time Frame
After study publication on a peer-reviewed journal in english language
IPD Sharing Access Criteria
On reasonable request to the Principal Investigator
Learn more about this trial
Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients
We'll reach out to this number within 24 hrs