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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Disorder

Intervention / Treatment
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* Procedure: Anesthesia Procedure
* Procedure: Anesthesia Procedure
* Procedure: Bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (conventional mechanical ventilation)<br>Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy. | Procedure: Anesthesia Procedure<br>* Receive anesthesia using laryngeal mask<br>* Other names: anesthesia;Procedure: Bronchoscopy<br>* Undergo standard of care bronchoscopy<br>|
| Experimental: Group II (VESPA)<br>Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy. | Procedure: Anesthesia Procedure<br>* Receive anesthesia using endotracheal tube<br>* Other names: anesthesia;Procedure: Bronchoscopy<br>* Undergo standard of care bronchoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |