Clinical trial NCT04311723: Ventilatory Strategy for the Prevention of Atelectasis During Bronchoscopy Under General Anesthesia, VESPA Trial
Official title: Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Presence or absence of new atelectasis for each segment
timeFrame: At the time of bronchoscopy
measure: Presence or absence of atelectasis within each of the 6 bronchial segments
timeFrame: During preoperative computed tomography (CT)
measure: Presence or absence of atelectasis for each patient
timeFrame: Up to 1 year
Secondary outcomes:
measure: Ventilatory strategy to prevent atelectasis (VESPA)-induced complications
timeFrame: Within 48 hours of bronchoscopy
measure: Bronchoscopy-induced complications
timeFrame: Within 48 hours of bronchoscopy
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Roberto F Casal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salahuddin M, Sarkiss M, Sagar AS, Vlahos I, Chang CH, Shah A, Sabath BF, Lin J, Song J, Moon T, Norman PH, Eapen GA, Grosu HB, Ost DE, Jimenez CA, Chintalapani G, Casal RF. Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia: A Multicenter Randomized Controlled Trial (Ventilatory Strategy to Prevent Atelectasis -VESPA- Trial). Chest. 2022 Dec;162(6):1393-1401. doi: 10.1016/j.chest.2022.06.045. Epub 2022 Jul 6.