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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Lung Disorder

Treatments: Procedure: Anesthesia Procedure; Procedure: Bronchoscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04311723

NCI-2020-00704 (Registry Identifier)

2019-0387 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group I (conventional mechanical ventilation)

Active Comparator group

Description:

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

Treatment:

Procedure: Bronchoscopy

Procedure: Anesthesia Procedure

Procedure: Anesthesia Procedure

Group II (VESPA)

Experimental group

Description:

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

Treatment:

Procedure: Bronchoscopy

Procedure: Anesthesia Procedure

Procedure: Anesthesia Procedure