Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients

Not Applicable

• Conditions: Acute Respiratory Failure
• Interventions: Procedure: Recruiting Maneuver

• Registration Number: NCT05200494
• Lead Sponsor: University Magna Graecia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Study Start: 2022-02-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible Bronchoscopy with Recruiting Maneuver	Recruiting Maneuver	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.

Primary Outcome Measures

Name	Time	Method
Lung Aeration through EIT	One hour after the end of the bronchoscopy	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	One hour after the end of the bronchoscopy	Improvement of lung aeration will be assess with Lung Ultrasound Score, as compared to baseline (before the bronchoscopy)

Secondary Outcome Measures

Name	Time	Method
Arterial Blood Gases	One hour after the end of the bronchoscopy	Arterial Blood Gases will be assessed through an arterial blood sample
Lung Aeration through EIT	Soon after the end of the bronchoscopy	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	Soon after the end of the bronchoscopy	Improvement of lung aeration will be assess with Lung Ultrasound Score , as compared to baseline (before the bronchoscopy)

Trial Locations

Locations (1)

AOU Mater Domini; 🇮🇹 Catanzaro, Italy