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Ventilatory Strategy for the Prevention of Atelectasis During Bronchoscopy Under General Anesthesia, VESPA Trial

Primary Purpose

Lung Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anesthesia Procedure
Anesthesia Procedure
Bronchoscopy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients undergoing bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
  • Recent (< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy
  • Voluntary informed consent to participate in the study

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
  • Pregnancy
  • Ascites
  • Known diaphragmatic paralysis
  • Air-trapping with residual volume > 150% of predicted
  • History of primary or secondary spontaneous pneumothorax
  • Lung bullae > 5 cm

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (conventional mechanical ventilation)

Group II (VESPA)

Arm Description

Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy.

Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.

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) and its 95% confidence interval will be estimated. The proportion of patients developing intraprocedural atelectasis will be compared between treatment and control arms, utilizing a 2-sided Chi-square test or Fisher's exact test to accomplish primary objective. Locations of atelectasis will be summarized in a frequency table, allowing for multiple locations in the same patient. The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range.
Presence or absence of atelectasis within each of the 6 bronchial segments
Will be determined using RP-EBUS. A segment will be identified as having a new atelectasis if there is an indication of solid- or semisolid-appearing lesion by RP-EBUS without a corresponding indication of solid tumor or atelectasis on the preoperative CT. If any of the two subsegments of any specific center has atelectasis, that segment will be considered atelectatic. The outcome of the reading will be defined by whatever pattern 2 or all 3 readers agree on. Locations of atelectasis will be summarized in a frequency table, allowing for multiple locations in the same patient. The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range.
Presence or absence of atelectasis for each patient
After identifying the presence or absence of new atelectasis for each segment, patients with at least 1 segment containing a new atelectasis will be determined to have atelectasis. Patients without atelectasis in any of the 6 segments will be determined to not have atelectasis. Patients with atelectasis and patients without atelectasis will be compared in terms of patient characteristics using a t-test or Wilcoxon test for continuous variables and Fisher's exact test or Chi-squared test for categorical variables.

Secondary Outcome Measures

Ventilatory strategy to prevent atelectasis (VESPA)-induced complications
Proportion of VESPA-induced complications will be estimated along with 95% credible interval.
Bronchoscopy-induced complications
Proportion of bronchoscopy-induced complications between VESPA and control arms will be estimated and compared by Chi-square test or Fisher's exact test.

Full Information

First Posted
March 13, 2020
Last Updated
August 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04311723
Brief Title
Ventilatory Strategy for the Prevention of Atelectasis During Bronchoscopy Under General Anesthesia, VESPA Trial
Official Title
Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
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 bronchoscopy under general anesthesia. Ventilatory strategy to prevent atelectasis (VESPA) may work better than standard of care mechanical ventilation to reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if our ventilatory strategy to prevent atelectasis (VESPA) can reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia when compared with conventional mechanical ventilation. SECONDARY OBJECTIVES: I. To describe proportion of VESPA-induced complications. II. To describe and compare proportion of bronchoscopy-induced complications in VESPA and control arms. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive anesthesia using a standard short breathing tube called laryngeal mask airway (LMA) and then undergo standard of care bronchoscopy. GROUP II: Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Image reviewers
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (conventional mechanical ventilation)
Arm Type
Active Comparator
Arm Description
Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy.
Arm Title
Group II (VESPA)
Arm Type
Experimental
Arm Description
Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.
Intervention Type
Procedure
Intervention Name(s)
Anesthesia Procedure
Other Intervention Name(s)
anesthesia
Intervention Description
Receive anesthesia using laryngeal mask
Intervention Type
Procedure
Intervention Name(s)
Anesthesia Procedure
Other Intervention Name(s)
anesthesia
Intervention Description
Receive anesthesia using endotracheal tube
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
Undergo standard of care bronchoscopy
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) and its 95% confidence interval will be estimated. The proportion of patients developing intraprocedural atelectasis will be compared between treatment and control arms, utilizing a 2-sided Chi-square test or Fisher's exact test to accomplish primary objective. Locations of atelectasis will be summarized in a frequency table, allowing for multiple locations in the same patient. The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range.
Time Frame
At the time of bronchoscopy
Title
Presence or absence of atelectasis within each of the 6 bronchial segments
Description
Will be determined using RP-EBUS. A segment will be identified as having a new atelectasis if there is an indication of solid- or semisolid-appearing lesion by RP-EBUS without a corresponding indication of solid tumor or atelectasis on the preoperative CT. If any of the two subsegments of any specific center has atelectasis, that segment will be considered atelectatic. The outcome of the reading will be defined by whatever pattern 2 or all 3 readers agree on. Locations of atelectasis will be summarized in a frequency table, allowing for multiple locations in the same patient. The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range.
Time Frame
During preoperative computed tomography (CT)
Title
Presence or absence of atelectasis for each patient
Description
After identifying the presence or absence of new atelectasis for each segment, patients with at least 1 segment containing a new atelectasis will be determined to have atelectasis. Patients without atelectasis in any of the 6 segments will be determined to not have atelectasis. Patients with atelectasis and patients without atelectasis will be compared in terms of patient characteristics using a t-test or Wilcoxon test for continuous variables and Fisher's exact test or Chi-squared test for categorical variables.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Ventilatory strategy to prevent atelectasis (VESPA)-induced complications
Description
Proportion of VESPA-induced complications will be estimated along with 95% credible interval.
Time Frame
Within 48 hours of bronchoscopy
Title
Bronchoscopy-induced complications
Description
Proportion of bronchoscopy-induced complications between VESPA and control arms will be estimated and compared by Chi-square test or Fisher's exact test.
Time Frame
Within 48 hours of bronchoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients undergoing bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions Recent (< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy Voluntary informed consent to participate in the study 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 Pregnancy Ascites Known diaphragmatic paralysis Air-trapping with residual volume > 150% of predicted History of primary or secondary spontaneous pneumothorax Lung bullae > 5 cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto F Casal
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35803302
Citation
Salahuddin M, Sarkiss M, Sagar AS, Vlahos I, Chang CH, Shah A, Sabath BF, Lin J, Song J, Moon T, Norman PH, Eapen GA, Grosu HB, Ost DE, Jimenez CA, Chintalapani G, Casal RF. Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia: A Multicenter Randomized Controlled Trial (Ventilatory Strategy to Prevent Atelectasis -VESPA- Trial). Chest. 2022 Dec;162(6):1393-1401. doi: 10.1016/j.chest.2022.06.045. Epub 2022 Jul 6.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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Ventilatory Strategy for the Prevention of Atelectasis During Bronchoscopy Under General Anesthesia, VESPA Trial

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