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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05200494
Other study ID # ICU Bronchoscopy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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