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

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05720845

Collaborator

(none)

Enrollment

Location

Arms

25.3

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Disorder	Procedure: VESPA Procedure: conventional mechanical ventilation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 8, 2023

Anticipated Primary Completion Date :

Jan 18, 2025

Anticipated Study Completion Date :

Mar 18, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional mechanical ventilation Conventional mechanical ventilation for General Anesthesia	Procedure: conventional mechanical ventilation Conventional mechanical ventilation for General Anesthesia.
Experimental: VESPA ventilatory strategy to prevent atelectasis for General Anesthesia	Procedure: VESPA Using Ventilatory strategy of prevent atelectasis for General Anesthesia.

Arm

Intervention/Treatment

Active Comparator: conventional mechanical ventilation

Conventional mechanical ventilation for General Anesthesia

Procedure: conventional mechanical ventilation

Conventional mechanical ventilation for General Anesthesia.

Experimental: VESPA

ventilatory strategy to prevent atelectasis for General Anesthesia

Procedure: VESPA

Using Ventilatory strategy of prevent atelectasis for General Anesthesia.

Outcome Measures

Primary Outcome Measures

Presence or absence of new atelectasis for each segment [During bronchoscopy, an average of 1 hour.]
The proportion of patients identified as developing intraprocedural atelectasis by radial probe endobronchial ultrasound (RP-EBUS)

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

Guangzhou Institute of Respiratory Disease

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ShiYue Li, Director of Department of Respiratory Medicine, Guangzhou Institute of Respiratory Disease

ClinicalTrials.gov Identifier:

NCT05720845

Other Study ID Numbers:

20230111

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ShiYue Li, Director of Department of Respiratory Medicine, Guangzhou Institute of Respiratory Disease

atelectasis

general anesthesia

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Feb 9, 2023