Pleural EffusionGRAVITASNCT03591952
Gravity- Versus Suction-driven Large Volume Thoracentesis
A study testing Suction-Driven Thoracentesis and Gravity-Driven Thoracentesis in people with Pleural Effusion, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Suction-Driven Thoracentesis and Gravity-Driven Thoracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 12 Sep 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral to pulmonary services for large-volume thoracentesis
- Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
- Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR
- CT-scan: maximum AP depth of the effusion ≥ 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR Ultrasound: effusion spanning at least three interspaces, with depth of 3 cm or greater in at least one interspace, while the patient sits upright.
- Age > 18
Who cannot join
- Inability to provide informed consent
- Patient has already been enrolled in this study
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Coagulopathy, with criteria left at the discretion of the operator
- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
Show all 9Show fewer
- Referral is for diagnostic thoracentesis only
- Presence of more than minimal septations and/or loculations on bedside pre-procedure ultrasound
- Inability to sit for the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Gravity- Versus Suction-driven Large Volume Thoracentesis: a Randomized Controlled Study
Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. While most proceduralists use suction to drain the pleural fluid, some drain effusions by gravity only. The investigators propose to evaluate whether gravity-driven thoracentesis results in less discomfort for patients than suction-drive thoracentesis.
Read the detailed description
Therapeutic thoracentesis aims to drain fluid from the pleural space to alleviate breathlessness. The amount of and speed with which the fluid can be safely drained in one setting is unclear, and likely depends on the physiology of the pleural effusion. The principle concern when draining a large amount of fluid quickly from the pleural space is that excessively negative pleural pressure may be generated; this occurs if the lung is unable to freely re-expand into the space previously occupied by fluid. Excessively negative pleural pressure and the resulting high transpulmonary pressure gradient are thought to be associated with several complications, including pneumothorax ex vacuo, chest discomfort, and re-expansion pulmonary edema (REPE). Evidence suggests that monitoring pleural pressures during thoracentesis via manometry does not mitigate this problem. In fact, data shows that whether manometry is used or not, most patients do experience clinically significant increase in chest discomfort during thoracentesis. Current methods for draining the pleural fluid include suction- (via vacuum bottles, wall suction or the use of large syringes with a one-way valve tubing system) or gravity-driven thoracentesis. Pressures generated by all suction techniques range from -200 to -500 cmH2O, and far exceed what are considered safe pleural pressures. Accordingly, in case of non-expandable lung, excessively negative pressures may develop quickly, exposing patients to complications. Some clinicians advocate for gravity drainage, which generates less negative pressures in the pleural space (specifically defined as the vertical distance between the catheter and the drainage bag, generally around -50 to -100 cmH20). While this technique is considered standard of care by some as it is potentially more comfortable for patients, it is also likely associated with longer procedures, and is not generally favored by clinicians who in general prefer suction drainage, despite the possible higher risk of complications.The investigators propose to study the impact of gravity- versus suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure, and consider as secondary endpoints: the duration of the procedure, the amount of pleural fluid drained, the rate of REPE, the rate of pneumothorax ex vacuo.
- Conditions
- Pleural Effusion
- Being tested
- Suction-Driven Thoracentesis, Gravity-Driven Thoracentesis
- Keywords
- Thoracentesis
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction-Driven ThoracentesisProcedure or surgery
Thoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier.
Gravity-Driven ThoracentesisProcedure or surgery
Thoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier.
| Study group | Role | What they receive |
|---|---|---|
| Suction | Active comparator | The pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care. Receives: Procedure: Suction-Driven Thoracentesis |
| Gravity | Experimental | The pleural fluid will be drained using gravity drainage to a bag positioned approximately 100 cm (approximately 40 inches) below the catheter entry point (see picture below) using the 40 inch tubing provided in the thoracentesis kit (CareFusion or Arrow). Receives: Procedure: Gravity-Driven Thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups
As measured in millimeters along a 10 cm Visual Analog Scale (VAS). The estimated minimal clinically important difference is 15 mm. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention versus (vs) control, will be made using the t-test or Wilcoxon Rank Sum test. Mixed model will be employed to assess the trend of pain score measured across pre-, intra-, and post-procedure.
Measured: One-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)
Secondary outcomes (6)
Incidence of pneumothorax
Assessed as either present or absent on the immediate post-procedure chest radiograph per radiologist interpretation. Descriptive statistics including percentages and frequencies will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention vs control, will be made using the Chi-square test.
Measured: 20 minutes after thoracentesis catheter is removed (on day 1)
Incidence of clinically-significant re-expansion pulmonary edema
Assessed as present if immediate post-procedure chest radiograph demonstrates new pulmonary edema per radiologist interpretation when compared to pre-procedure radiograph in the hemithorax that underwent thoracentesis, and subject has post-procedure new-onset or worsened hypoxic respiratory failure. Descriptive statistics including percentages and frequencies will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention vs control, will be made using the Chi-square test.
Measured: 20 minutes after thoracentesis catheter is removed (on day 1)
Incidence of radiographically-apparent re-expansion pulmonary edema
Assessed as present if immediate post-procedure chest radiograph demonstrates new pulmonary edema per radiologist interpretation when compared to pre-procedure radiograph in the hemithorax that underwent thoracentesis. Descriptive statistics including percentages and frequencies will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention vs control, will be made using the Chi-square test.
Measured: 20 minutes after thoracentesis catheter is removed (on day 1)
Volume of pleural fluid removed by the thoracentesis procedure
Measured in milliliters. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention vs control, will be made using the t-test or Wilcoxon Rank Sum test.
Measured: Immediately after the thoracentesis catheter is removed, on day 1
Improvement in dyspnea scores
Assessed in millimeters along a 10 cm Visual Analog Scale (VAS), from pre-procedure (baseline) to 5 minutes after completion of the procedure. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention vs control, will be made using either the t-test or Wilcoxon Rank Sum test.
Measured: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
Duration of procedure
Measured in seconds, assessed from the time the thoracentesis catheter is introduced to the time the catheter is removed. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention vs control, will be made using the t-test or Wilcoxon Rank Sum test.
Measured: During the procedure, on day 1, intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Aug 2018
- Primary completion5 Apr 2019
- Study completion12 Sep 2019
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 Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt University Medical Center
- Investigators
- Fabien Maldonado, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591952
- Sponsor's protocol ID
- 180339
- Other IDs
- 180339
- Acronym
- GRAVITAS
- Status last verified
- Feb 2022
- First submitted
- 11 Jun 2018
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lentz RJ, Shojaee S, Grosu HB, Rickman OB, Roller L, Pannu JK, DePew ZS, Debiane LG, Cicenia JC, Akulian J, Walston C, Sanchez TM, Davidson KR, Jagan N, Ahmad S, Gilbert C, Huggins JT, Chen H, Light RW, Yarmus L, Feller-Kopman D, Lee H, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial. Chest. 2020 Mar;157(3):702-711. doi: 10.1016/j.chest.2019.10.025. Epub 2019 Nov 9.
PubMed 31711990
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravity- Versus Suction-driven Large Volume Thoracentesis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03591952
- Acronym / sponsor ID
- GRAVITAS / 180339
- Conditions
- Pleural Effusion
- Keywords
- Thoracentesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 19 Jul 2018 (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.
Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. While most proceduralists use suction to drain the pleural fluid, some drain effusions by gravity only. The investigators propose to evaluate whether gravity-driven thoracentesis results in less discomfort for patients than suction-drive thoracentesis.
Detailed description
Therapeutic thoracentesis aims to drain fluid from the pleural space to alleviate breathlessness. The amount of and speed with which the fluid can be safely drained in one setting is unclear, and likely depends on the physiology of the pleural effusion. The principle concern when draining a large amount of fluid quickly from the pleural space is that excessively negative pleural pressure may be generated; this occurs if the lung is unable to freely re-expand into the space previously occupied by fluid. Excessively negative pleural pressure and the resulting high transpulmonary pressure gradient are thought to be associated with several complications, including pneumothorax ex vacuo, chest discomfort, and re-expansion pulmonary edema (REPE). Evidence suggests that monitoring pleural pressures during thoracentesis via manometry does not mitigate this problem. In fact, data shows that whether manometry is used or not, most patients do experience clinically significant increase in chest discomfort during thoracentesis. Current methods for draining the pleural fluid include suction- (via vacuum bottles, wall suction or the use of large syringes with a one-way valve tubing system) or gravity-driven thoracentesis. Pressures generated by all suction techniques range from -200 to -500 cmH2O, and far exceed what are considered safe pleural pressures. Accordingly, in case of non-expandable lung, excessively negative pressures may develop quickly, exposing patients to complications. Some clinicians advocate for gravity drainage, which generates less negative pressures in the pleural space (specifically defined as the vertical distance between the catheter and the drainage bag, generally around -50 to -100 cmH20). While this technique is considered standard of care by some as it is potentially more comfortable for patients, it is also likely associated with longer procedures, and is not generally favored by clinicians who in general prefer suction drainage, despite the possible higher risk of complications.The investigators propose to study the impact of gravity- versus suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure, and consider as secondary endpoints: the duration of the procedure, the amount of pleural fluid drained, the rate of REPE, the rate of pneumothorax ex vacuo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suction | Active comparator | Procedure: Suction-Driven ThoracentesisThe pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care. |
| Gravity | Experimental | Procedure: Gravity-Driven ThoracentesisThe pleural fluid will be drained using gravity drainage to a bag positioned approximately 100 cm (approximately 40 inches) below the catheter entry point (see picture below) using the 40 inch tubing provided in the thoracentesis kit (CareFusion or Arrow). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referral to pulmonary services for large-volume thoracentesis
- Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
- Age > 18
Key exclusion criteria (9 listed)
- Inability to provide informed consent
- Patient has already been enrolled in this study
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
- Referral is for diagnostic thoracentesis only
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 |
|---|---|---|
| Suction-Driven ThoracentesisThoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier. | Procedure or surgery | Suction |
| Gravity-Driven ThoracentesisThoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier. | Procedure or surgery | Gravity |
Primary outcome
Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups
Time frame: One-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)
As measured in millimeters along a 10 cm Visual Analog Scale (VAS). The estimated minimal clinically important difference is 15 mm. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention versus (vs) control, will be made using the t-test or Wilcoxon Rank Sum test. Mixed model will be employed to assess the trend of pain score measured across pre-, intra-, and post-procedure.
6 secondary outcomes
Incidence of pneumothorax
Time frame: 20 minutes after thoracentesis catheter is removed (on day 1)
Incidence of clinically-significant re-expansion pulmonary edema
Time frame: 20 minutes after thoracentesis catheter is removed (on day 1)
Incidence of radiographically-apparent re-expansion pulmonary edema
Time frame: 20 minutes after thoracentesis catheter is removed (on day 1)
Volume of pleural fluid removed by the thoracentesis procedure
Time frame: Immediately after the thoracentesis catheter is removed, on day 1
Improvement in dyspnea scores
Time frame: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
Duration of procedure
Time frame: During the procedure, on day 1, intraoperative
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 14 Mar 2022.
- Derived from this study: PubMed 31711990Lentz RJ, Shojaee S, Grosu HB, Rickman OB, Roller L, Pannu JK, DePew ZS, Debiane LG, Cicenia JC, Akulian J, Walston C, Sanchez TM, Davidson KR, Jagan N, Ahmad S, Gilbert C, Huggins JT, Chen H, Light RW, Yarmus L, Feller-Kopman D, Lee H, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial. Chest. 2020 Mar;157(3):702-711. doi: 10.1016/j.chest.2019.10.025. Epub 2019 Nov 9.
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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.
Fabien Maldonado, MD principal investigator
Vanderbilt University Medical 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 Suction-Driven Thoracentesis and Gravity-Driven Thoracentesis in people with Pleural Effusion, run by Vanderbilt University Medical 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 5 inclusion and 9 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 14 Mar 2022. 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?
Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups (time frame: One-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)). 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 NCT03591952, 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 14 Mar 2022.