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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-27

Study Completion Date

2024-03-21

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.

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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.

Conditions

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Lung Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Image reviewers

Study Groups

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Group I (conventional mechanical ventilation)

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

Group Type ACTIVE_COMPARATOR

Anesthesia Procedure

Intervention Type PROCEDURE

Receive anesthesia using laryngeal mask

Bronchoscopy

Intervention Type PROCEDURE

Undergo standard of care bronchoscopy

Group II (VESPA)

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

Group Type EXPERIMENTAL

Anesthesia Procedure

Intervention Type PROCEDURE

Receive anesthesia using endotracheal tube

Bronchoscopy

Intervention Type PROCEDURE

Undergo standard of care bronchoscopy

Interventions

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Anesthesia Procedure

Receive anesthesia using laryngeal mask

Intervention Type PROCEDURE

Anesthesia Procedure

Receive anesthesia using endotracheal tube

Intervention Type PROCEDURE

Bronchoscopy

Undergo standard of care bronchoscopy

Intervention Type PROCEDURE

Other Intervention Names

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anesthesia anesthesia

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes