Back to resultsEffects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
Primary Purpose
Lung Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
VESPA
conventional mechanical ventilation
Sponsored by
About this trial
This is an interventional other trial for Lung Disorder focused on measuring atelectasis, general anesthesia
Eligibility Criteria
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
Sites / Locations
- Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional mechanical ventilation
VESPA
Arm Description
Conventional mechanical ventilation for General Anesthesia
ventilatory strategy to prevent atelectasis for General Anesthesia
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Ventilation-induced complications
Bronchoscopy-induced complications
Assess the regional ventilation distribution by Electrical impedance tomography (EIT)
Full Information
NCT ID
NCT05720845
First Posted
January 12, 2023
Last Updated
January 31, 2023
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT05720845
Brief Title
Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
Official Title
Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 8, 2023 (Anticipated)
Primary Completion Date
January 18, 2025 (Anticipated)
Study Completion Date
March 18, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disorder
Keywords
atelectasis, general anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional mechanical ventilation
Arm Type
Active Comparator
Arm Description
Conventional mechanical ventilation for General Anesthesia
Arm Title
VESPA
Arm Type
Experimental
Arm Description
ventilatory strategy to prevent atelectasis for General Anesthesia
Intervention Type
Procedure
Intervention Name(s)
VESPA
Intervention Description
Using Ventilatory strategy of prevent atelectasis for General Anesthesia.
Intervention Type
Procedure
Intervention Name(s)
conventional mechanical ventilation
Intervention Description
Conventional mechanical ventilation for General Anesthesia.
Primary Outcome Measure Information:
Title
Presence or absence of new atelectasis for each segment
Description
The proportion of patients identified as developing intraprocedural atelectasis by radial probe endobronchial ultrasound (RP-EBUS)
Time Frame
During bronchoscopy, an average of 1 hour.
Secondary Outcome Measure Information:
Title
Ventilation-induced complications
Time Frame
Within 48 hours of bronchoscopy
Title
Bronchoscopy-induced complications
Time Frame
Within 48 hours of bronchoscopy
Title
Assess the regional ventilation distribution by Electrical impedance tomography (EIT)
Time Frame
During bronchoscopy, an average of 1 hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
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