Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients

NCT05200494 | Unknown

• 1 other identifier: ICU Bronchoscopy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Secretions; Bronchoscopy; Lung Ultrasound; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Arterial Blood Gases

  Soon after the end of the bronchoscopy

• Arterial Blood Gases

  One hour after the end of the bronchoscopy

• Lung Aeration through EIT

  Soon after the end of the bronchoscopy

• Lung Aeration through Lung Ultrasound

  Soon after the end of the bronchoscopy

Study Arms (2)

Flexible Bronchoscopy without Recruiting Maneuver

NO INTERVENTION

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

Flexible Bronchoscopy with Recruiting Maneuver

EXPERIMENTAL

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.

Procedure: Recruiting Maneuver

Interventions

Recruiting Maneuver PROCEDURE

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

Flexible Bronchoscopy with Recruiting Maneuver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• invasive mechanical ventilation
• need for flexible bronchoscopy to remove secretion plug from the airway

You may not qualify if:

• 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);

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

+393475395967; longhini.federico@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked since he/she will be not present at the end of the procedure, when the intervention (Recruiting Maneuver) will be applied or not.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After study publication on a peer-reviewed journal in english language
• Access Criteria: On reasonable request to the Principal Investigator

Locations

IT (1)