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

NCT04311723 | Completed

• 2 other identifiers: 2019-0387NCI-2020-00704
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Ventilatory strategy to prevent atelectasis (VESPA)-induced complications

  Within 48 hours of bronchoscopy

• Bronchoscopy-induced complications

  Within 48 hours of bronchoscopy

Study Arms (2)

Group I (conventional mechanical ventilation)

ACTIVE COMPARATOR

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

Procedure: Anesthesia Procedure; Procedure: Bronchoscopy

Group II (VESPA)

EXPERIMENTAL

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

Procedure: Anesthesia Procedure; Procedure: Bronchoscopy

Interventions

Anesthesia Procedure PROCEDURE

Receive anesthesia using laryngeal mask

Also known as: anesthesia

Group I (conventional mechanical ventilation)

Bronchoscopy PROCEDURE

Undergo standard of care bronchoscopy

Group I (conventional mechanical ventilation); Group II (VESPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 35803302 DERIVED

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Diseases

Interventions

Anesthesia; Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Roberto F Casal

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Image reviewers
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: May 27, 2020
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-03

Locations

US (1)