Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.

NCT05720845 | Unknown

• 1 other identifier: 20230111
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing interventional pulmonology procedures under general anesthesia. Ventilatory strategy to prevent reduce the intra-procedural development of atelectasis during interventional pulmonology procedures under general anesthesia.

Conditions

Lung Disorder

Keywords

atelectasis; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Presence or absence of new atelectasis for each segment

  The proportion of patients identified as developing intraprocedural atelectasis by radial probe endobronchial ultrasound (RP-EBUS)

  During bronchoscopy, an average of 1 hour.

Secondary Outcomes (3)

• Ventilation-induced complications

  Within 48 hours of bronchoscopy

• Bronchoscopy-induced complications

  Within 48 hours of bronchoscopy

• Assess the regional ventilation distribution by Electrical impedance tomography (EIT)

  During bronchoscopy, an average of 1 hour.

Study Arms (2)

conventional mechanical ventilation

ACTIVE COMPARATOR

Conventional mechanical ventilation for General Anesthesia

Procedure: conventional mechanical ventilation

VESPA

EXPERIMENTAL

ventilatory strategy to prevent atelectasis for General Anesthesia

Procedure: VESPA

Interventions

VESPA PROCEDURE

Using Ventilatory strategy of prevent atelectasis for General Anesthesia.

VESPA

conventional mechanical ventilation PROCEDURE

Conventional mechanical ventilation for General Anesthesia.

conventional mechanical ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing interventional pulmonology procedures with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
• Recent (\< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy

You may not qualify if:

• Patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung (right/left \[R/L\] B6, 9, or 10 bronchial segments) as seen on most recent CT
• History of primary or secondary spontaneous pneumothorax

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory Medicine

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 9, 2023
• Study Start: February 8, 2023
• Primary Completion: January 18, 2025
• Study Completion: March 18, 2025
• Last Updated: February 9, 2023

Record last verified: 2023-01

Locations

CN (1)