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

• ClinicalTrials.gov Identifier: NCT04311723
• Recruitment Status: Recruiting
• First Posted: March 17, 2020
• Last Update Posted: November 6, 2020
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Disorder	Procedure: Anesthesia Procedure; Procedure: Bronchoscopy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Image reviewers
• Primary Purpose: Diagnostic
• Official Title: Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)
• Actual Study Start Date: May 27, 2020
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group I (conventional mechanical ventilation); Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy.	Procedure: Anesthesia Procedure; Receive anesthesia using laryngeal mask; Other Name: anesthesia; Procedure: Bronchoscopy; Undergo standard of care bronchoscopy
Experimental: Group II (VESPA); Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.	Procedure: Anesthesia Procedure; Receive anesthesia using endotracheal tube; Other Name: anesthesia; Procedure: Bronchoscopy; Undergo standard of care bronchoscopy

Outcome Measures

Primary Outcome Measures :

1. Presence or absence of new atelectasis for each segment [ Time Frame: At the time of bronchoscopy ]
   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.
2. Presence or absence of atelectasis within each of the 6 bronchial segments [ Time Frame: During preoperative computed tomography (CT) ]
   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.
3. Presence or absence of atelectasis for each patient [ Time Frame: Up to 1 year ]
   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.

Secondary Outcome Measures :

1. Ventilatory strategy to prevent atelectasis (VESPA)-induced complications [ Time Frame: Within 48 hours of bronchoscopy ]
   Proportion of VESPA-induced complications will be estimated along with 95% credible interval.
2. Bronchoscopy-induced complications [ Time Frame: Within 48 hours of bronchoscopy ]
   Proportion of bronchoscopy-induced complications between VESPA and control arms will be estimated and compared by Chi-square test or Fisher's exact test.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Roberto F Casal; 713-792-6238; rfcasal@mdanderson.org

Locations

United States, Texas

M D Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: Roberto F. Casal 713-792-6238

Principal Investigator: Roberto F. Casal

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Roberto F Casal; M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center Website 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04311723
• Other Study ID Numbers: 2019-0387; NCI-2020-00704 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2019-0387 ( Other Identifier: M D Anderson Cancer Center ); P30CA016672 ( U.S. NIH Grant/Contract )
• First Posted: March 17, 2020
• Last Update Posted: November 6, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pulmonary Atelectasis; Lung Diseases; Respiratory Tract Diseases; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs