ThoracentesisNCT05131945
GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GRAWITAS Study)
A study testing Standard Suction Thoracentesis and Gravity Thoracentesis in people with Thoracentesis and Pleural Effusions, Chronic, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracentesis, Pleural Effusions, Chronic, Pulmonary Edema
- What is being tested?
- Standard Suction Thoracentesis and Gravity Thoracentesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 10 Sep 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
- 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 intercostal space, while the patient sits upright.
- Age >/= 18
Who cannot join
- Inability to provide informed consent
- 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
- Referral is for diagnostic thoracentesis only
Show all 9Show fewer
- Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound
- Inability to sit for the procedure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure.
This study is a multicenter, single-blinded, randomized controlled trial designed to compare chest discomfort between gravity-driven and wall suction-driven therapeutic thoracentesis. Patients will be stratified by study centers, and randomly assigned to intervention and control arms; and will remain blinding to their group assignment during the procedure.
Read the detailed description
Aims and Objectives:
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure.
Expected Outcomes:
We anticipate that gravity driven therapeutic thoracentesis will result in improved clinical outcomes compared to wall suction driven thoracentesis, defined by less chest discomfort throughout the procedure as measured at 5 minutes post-procedure (primary endpoint).
Primary endpoint:
The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment ("On average, how much discomfort have you felt during the procedure?"). The primary endpoint is defined as the overall procedural chest pain scored 5 minutes following the procedure.
This study is a randomized controlled trial designed to compare the changes of chest pain scores between gravity-driven therapeutic thoracentesis and wall suction-driven thoracentesis. The estimated minimal clinically important difference of the change is 10.
Secondary endpoints:
- Duration of procedure timed from the beginning of fluid drainage to catheter removal.
- Differences in narcotics used after the procedure.
- Incidence of pneumothorax detected on the post procedural CXR
- Incidence of clinically apparent re-expansion pulmonary edema
- Incidence of radiographically apparent re-expansion pulmonary edema detected on the post procedural CXR
- Conditions
- Thoracentesis, Pleural Effusions, Chronic, Pulmonary Edema
- Being tested
- Standard Suction Thoracentesis, Gravity Thoracentesis
- Medical subject headings
- Pleural Effusion, Bronchiolitis Obliterans Syndrome, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Suction ThoracentesisOther
a procedure that removes excess fluid from the space in between your lungs and chest wall
Gravity ThoracentesisOther
a procedure that removes excess fluid from the space in between your lungs and chest wall
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard Suction Thoracentesis | Experimental | treatment techniques suction is a standard of care and used for draining fluid around the lung. Receives: Other: Standard Suction Thoracentesis; Other: Gravity Thoracentesis |
| Group 2: Gravity Thoracentesis. | Experimental | treatment techniques (gravity ) is a standard of care and used for draining fluid around the lung. Receives: Other: Standard Suction Thoracentesis; Other: Gravity Thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall procedural chest pain questionnaire
The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start10 Dec 2018
- Primary completion10 Sep 2024
- Study completion10 Sep 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 ThoracentesisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horianna Grosu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131945
- Sponsor's protocol ID
- 2018-0654
- Other IDs
- NCI-2021-13202
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shojaee S, Pannu J, Yarmus L, Fantin A, MacRosty C, Bassett R Jr, Debiane L, DePew ZS, Faiz SA, Jimenez CA, Avasarala SK, Vakil E, DeMaio A, Bashoura L, Keshava K, Ferguson T, Adachi R, Eapen GA, Ost DE, Bashour S, Khan A, Shannon V, Sheshadri A, Casal RF, Evans SE, Pew K, Castaldo N, Balachandran DD, Patruno V, Lentz R, Pai C, Maldonado F, Roller L, Ma J, Zaveri J, Los J, Vaquero L, Ordonez E, Yermakhanova G, Akulian J, Burks C, Almario RR, Sauve M, Pettee J, Noor LZ, Arain MH, Grosu HB. Gravity- vs Wall Suction-Driven Large-Volume Thoracentesis: A Randomized Controlled Study. Chest. 2024 Dec;166(6):1573-1582. doi: 10.1016/j.chest.2024.05.046. Epub 2024 Jul 18.
PubMed 39029784
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GRAWITAS Study)
- ClinicalTrials.gov ID
- NCT05131945
- Acronym / sponsor ID
- 2018-0654
- Conditions
- Thoracentesis, Pleural Effusions, Chronic, Pulmonary Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 23 Nov 2021 (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.
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure.
This study is a multicenter, single-blinded, randomized controlled trial designed to compare chest discomfort between gravity-driven and wall suction-driven therapeutic thoracentesis. Patients will be stratified by study centers, and randomly assigned to intervention and control arms; and will remain blinding to their group assignment during the procedure.
Detailed description
Aims and Objectives:
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure.
Expected Outcomes:
We anticipate that gravity driven therapeutic thoracentesis will result in improved clinical outcomes compared to wall suction driven thoracentesis, defined by less chest discomfort throughout the procedure as measured at 5 minutes post-procedure (primary endpoint).
Primary endpoint:
The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment ("On average, how much discomfort have you felt during the procedure?"). The primary endpoint is defined as the overall procedural chest pain scored 5 minutes following the procedure.
This study is a randomized controlled trial designed to compare the changes of chest pain scores between gravity-driven therapeutic thoracentesis and wall suction-driven thoracentesis. The estimated minimal clinically important difference of the change is 10.
Secondary endpoints:
- Duration of procedure timed from the beginning of fluid drainage to catheter removal.
- Differences in narcotics used after the procedure.
- Incidence of pneumothorax detected on the post procedural CXR
- Incidence of clinically apparent re-expansion pulmonary edema
- Incidence of radiographically apparent re-expansion pulmonary edema detected on the post procedural CXR
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard Suction Thoracentesis | Experimental | Other: Standard Suction Thoracentesis, Other: Gravity Thoracentesistreatment techniques suction is a standard of care and used for draining fluid around the lung. |
| Group 2: Gravity Thoracentesis. | Experimental | Other: Standard Suction Thoracentesis, Other: Gravity Thoracentesistreatment techniques (gravity ) is a standard of care and used for draining fluid around the lung. |
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
- 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
- Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound
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 |
|---|---|---|
| Standard Suction Thoracentesisa procedure that removes excess fluid from the space in between your lungs and chest wall | Other | Group 1: Standard Suction Thoracentesis, Group 2: Gravity Thoracentesis. |
| Gravity Thoracentesisa procedure that removes excess fluid from the space in between your lungs and chest wall | Other | Group 1: Standard Suction Thoracentesis, Group 2: Gravity Thoracentesis. |
Primary outcome
The overall procedural chest pain questionnaire
Time frame: through study completion, an average of 1 year
The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment
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 19 Sep 2024.
- Derived from this study: PubMed 39029784Shojaee S, Pannu J, Yarmus L, Fantin A, MacRosty C, Bassett R Jr, Debiane L, DePew ZS, Faiz SA, Jimenez CA, Avasarala SK, Vakil E, DeMaio A, Bashoura L, Keshava K, Ferguson T, Adachi R, Eapen GA, Ost DE, Bashour S, Khan A, Shannon V, Sheshadri A, Casal RF, Evans SE, Pew K, Castaldo N, Balachandran DD, Patruno V, Lentz R, Pai C, Maldonado F, Roller L, Ma J, Zaveri J, Los J, Vaquero L, Ordonez E, Yermakhanova G, Akulian J, Burks C, Almario RR, Sauve M, Pettee J, Noor LZ, Arain MH, Grosu HB. Gravity- vs Wall Suction-Driven Large-Volume Thoracentesis: A Randomized Controlled Study. Chest. 2024 Dec;166(6):1573-1582. doi: 10.1016/j.chest.2024.05.046. Epub 2024 Jul 18.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Thoracentesis
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Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
Pleural Effusion, Frist Time Indication to Perform a Thoracentesis
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.
Horianna Grosu, MD 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 Standard Suction Thoracentesis and Gravity Thoracentesis in people with Thoracentesis and Pleural Effusions, Chronic, 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 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 19 Sep 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?
The overall procedural chest pain questionnaire (time frame: through study completion, an average of 1 year). 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 NCT05131945, 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 19 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.