Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients

Acute Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05200494
• Other study ID #: ICU Bronchoscopy
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: University Magna Graecia
• Contact: Federico Longhini, MD
• Phone: +393475395967
• Email: longhini.federico[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Recruiting Maneuver
Airway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy

Locations

Country	Name	City	State
Italy	AOU Mater Domini	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	One hour after the end of the bronchoscopy
Primary	Lung Aeration through Lung Ultrasound	Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)	One hour after the end of the bronchoscopy
Secondary	Arterial Blood Gases	Arterial Blood Gases will be assessed through an arterial blood sample	Soon after the end of the bronchoscopy
Secondary	Arterial Blood Gases	Arterial Blood Gases will be assessed through an arterial blood sample	One hour after the end of the bronchoscopy
Secondary	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)	Soon after the end of the bronchoscopy
Secondary	Lung Aeration through Lung Ultrasound	Improvement of lung aeration will be assess with Lung Ultrasound Score , as compared to baseline (before the bronchoscopy)	Soon after the end of the bronchoscopy