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

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

Sponsors

Lead sponsor: M.D. Anderson Cancer Center

Collaborator: National Cancer Institute (NCI)

Source 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.

Overall Status Not yet recruiting
Start Date March 31, 2020
Completion Date September 30, 2020
Primary Completion Date September 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Presence or absence of new atelectasis for each segment At the time of bronchoscopy
Presence or absence of new atelectasis for each segment At the time of bronchoscopy
Presence or absence of new atelectasis for each segment At the time of bronchoscopy
Presence or absence of atelectasis within each of the 6 bronchial segments During preoperative computed tomography (CT)
Presence or absence of atelectasis within each of the 6 bronchial segments During preoperative computed tomography (CT)
Presence or absence of atelectasis within each of the 6 bronchial segments During preoperative computed tomography (CT)
Presence or absence of atelectasis for each patient Up to 1 year
Presence or absence of atelectasis for each patient Up to 1 year
Presence or absence of atelectasis for each patient Up to 1 year
Secondary Outcome
Measure Time Frame
Ventilatory strategy to prevent atelectasis (VESPA)-induced complications Within 48 hours of bronchoscopy
Bronchoscopy-induced complications Within 48 hours of bronchoscopy
Enrollment 76
Condition
Intervention

Intervention type: Procedure

Intervention name: Anesthesia Procedure

Description: Receive anesthesia using laryngeal mask

Arm group label: Group I (conventional mechanical ventilation)

Other name: anesthesia

Intervention type: Procedure

Intervention name: Anesthesia Procedure

Description: Receive anesthesia using endotracheal tube

Arm group label: Group II (VESPA)

Other name: anesthesia

Intervention type: Procedure

Intervention name: Bronchoscopy

Description: Undergo standard of care bronchoscopy

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Roberto F Casal Principal Investigator M.D. Anderson Cancer Center
Overall Contact

Last name: Roberto F Casal

Phone: 713-792-6238

Email: [email protected]

Location
facility contact investigator
M D Anderson Cancer Center Roberto F. Casal 713-792-6238 Roberto F. Casal Principal Investigator
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group I (conventional mechanical ventilation)

Arm group type: Active Comparator

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

Arm group label: Group II (VESPA)

Arm group type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Outcomes Assessor)

Masking description: Image reviewers

Source: ClinicalTrials.gov