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

Lung Disorder Clinical Trial

Official title:

Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311723
• Other study ID #: 2019-0387
• Secondary ID: NCI-2020-0070420
• Status: Completed
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: March 21, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Disorder
• Pulmonary Atelectasis

Intervention

Procedure:
• Anesthesia Procedure
Receive anesthesia using laryngeal mask
• Anesthesia Procedure
Receive anesthesia using endotracheal tube
• Bronchoscopy
Undergo standard of care bronchoscopy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the time of bronchoscopy
Primary	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.	During preoperative computed tomography (CT)
Primary	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.	Up to 1 year
Secondary	Ventilatory strategy to prevent atelectasis (VESPA)-induced complications	Proportion of VESPA-induced complications will be estimated along with 95% credible interval.	Within 48 hours of bronchoscopy
Secondary	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.	Within 48 hours of bronchoscopy

External Links

•   MD Anderson Cancer Center Website