Lung DisorderNCT04311723
Ventilatory Strategy for the Prevention of Atelectasis During Bronchoscopy Under General Anesthesia, VESPA Trial
A study testing Anesthesia Procedure and Bronchoscopy in people with Lung Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Disorder
- What is being tested?
- Anesthesia Procedure and Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Lung Disorder
- Being tested
- Anesthesia Procedure, Bronchoscopy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia ProcedureProcedure or surgery
Also called anesthesia
Receive anesthesia using laryngeal mask
Anesthesia ProcedureProcedure or surgery
Also called anesthesia
Receive anesthesia using endotracheal tube
BronchoscopyProcedure or surgery
Undergo standard of care bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Anesthesia Procedure; Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (2)
Ventilatory strategy to prevent atelectasis (VESPA)-induced complications
Proportion of VESPA-induced complications will be estimated along with 95% credible interval.
Measured: Within 48 hours of bronchoscopy
Bronchoscopy-induced complications
Proportion of bronchoscopy-induced complications between VESPA and control arms will be estimated and compared by Chi-square test or Fisher's exact test.
Measured: Within 48 hours of bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start27 May 2020
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roberto F Casal, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311723
- Sponsor's protocol ID
- 2019-0387
- Other IDs
- NCI-2020-00704, 2019-0387
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2020
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35803302
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)
- ClinicalTrials.gov ID
- NCT04311723
- Acronym / sponsor ID
- 2019-0387
- Conditions
- Lung Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 May 2020 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (conventional mechanical ventilation) | Active comparator | Procedure: Anesthesia Procedure, Procedure: BronchoscopyPatients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy. |
| Group II (VESPA) | Experimental | Procedure: Anesthesia Procedure, Procedure: BronchoscopyPatients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia ProcedureAlso: anesthesiaReceive anesthesia using laryngeal mask | Procedure or surgery | Group I (conventional mechanical ventilation) |
| Anesthesia ProcedureAlso: anesthesiaReceive anesthesia using endotracheal tube | Procedure or surgery | Group II (VESPA) |
| BronchoscopyUndergo standard of care bronchoscopy | Procedure or surgery | Group I (conventional mechanical ventilation), Group II (VESPA) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Ventilatory strategy to prevent atelectasis (VESPA)-induced complications
Time frame: Within 48 hours of bronchoscopy
Bronchoscopy-induced complications
Time frame: Within 48 hours of bronchoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 35803302Salahuddin 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.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto F Casal principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia Procedure and Bronchoscopy in people with Lung Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of new atelectasis for each segment (time frame: At the time of bronchoscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.