Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients

NCT ID: NCT05200494

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-31

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.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Flexible Bronchoscopy without Recruiting Maneuver

At the end of the bronchoscopy, no further interventions or ventilator maneuvers will be done.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Flexible Bronchoscopy with 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.

Group Type: EXPERIMENTAL

Recruiting Maneuver

Intervention Type: PROCEDURE

Airway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy

Interventions

Recruiting Maneuver

Airway pressure will be increased to 30 cmH2O for 30 seconds at the end of the bronchoscopy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Federico Longhini

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

AOU Mater Domini

Catanzaro, , Italy

Countries

Italy

Central Contacts

Federico Longhini, MD

Role: CONTACT

longhini.federico@gmail.com

+393475395967

Other Identifiers

ICU Bronchoscopy

Identifier Type: -

Identifier Source: org_study_id