Clinical trial NCT05200494: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Secretions
Bronchoscopy
Lung Ultrasound
Electrical Impedance Tomography
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Lung Aeration through EIT
timeFrame: One hour after the end of the bronchoscopy
measure: Lung Aeration through Lung Ultrasound
timeFrame: One hour after the end of the bronchoscopy
Secondary outcomes:
measure: Arterial Blood Gases
timeFrame: Soon after the end of the bronchoscopy
measure: Arterial Blood Gases
timeFrame: One hour after the end of the bronchoscopy
measure: Lung Aeration through EIT
timeFrame: Soon after the end of the bronchoscopy
measure: Lung Aeration through Lung Ultrasound
timeFrame: Soon after the end of the bronchoscopy
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: