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

January 31, 2023 updated by: ShiYue Li, Guangzhou Institute of Respiratory Disease
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Ventilation-induced complications
Time Frame: Within 48 hours of bronchoscopy
Within 48 hours of bronchoscopy
Bronchoscopy-induced complications
Time Frame: Within 48 hours of bronchoscopy
Within 48 hours of bronchoscopy
Assess the regional ventilation distribution by Electrical impedance tomography (EIT)
Time Frame: During bronchoscopy, an average of 1 hour.
During bronchoscopy, an average of 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 8, 2023

Primary Completion (ANTICIPATED)

January 18, 2025

Study Completion (ANTICIPATED)

March 18, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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