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

Not Applicable

Completed

• Conditions: Lung Disorder
• Interventions: Procedure: Anesthesia Procedure; Procedure: Bronchoscopy

• Registration Number: NCT04311723
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2020-05-27
• Status Verified: 2024-03
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (conventional mechanical ventilation)	Bronchoscopy	Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy.
Group II (VESPA)	Anesthesia Procedure	Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.
Group I (conventional mechanical ventilation)	Anesthesia Procedure	Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy.
Group II (VESPA)	Bronchoscopy	Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.

Primary Outcome Measures

Name	Time	Method
Presence or absence of atelectasis within each of the 6 bronchial segments	During preoperative computed tomography (CT)	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 new atelectasis for each segment	At the time of bronchoscopy	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 for each patient	Up to 1 year	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

Name	Time	Method
Bronchoscopy-induced complications	Within 48 hours of bronchoscopy	Proportion of bronchoscopy-induced complications between VESPA and control arms will be estimated and compared by Chi-square test or Fisher's exact test.
Ventilatory strategy to prevent atelectasis (VESPA)-induced complications	Within 48 hours of bronchoscopy	Proportion of VESPA-induced complications will be estimated along with 95% credible interval.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States