Pleural EffusionNCT02677883
Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis
A study testing Manometry-guided thoracentesis and Symptom-guided thoracentesis in people with Pleural Effusion, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This randomized controlled trial attempts to determine whether the measurement of pleural pressures during therapeutic thoracentesis affects the development of chest discomfort after the procedure. During thoracentesis, pleural fluid is drained from the pleural space, resulting in lung expansion. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Manometry-guided thoracentesis and Symptom-guided thoracentesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 8 Mar 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral to pulmonary or interventional radiology services for large-volume thoracentesis
- Presence of a symptomatic moderate or large free-flowing pleural effusion on the basis of:
- Chest radiograph: effusion filling >= 1/3 the hemithorax, OR
- Computed tomography (CT)-scan: maximum anteroposterior (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 rib spaces with depth of >= 3 cm
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
- Manometry felt to be clinically indicated
- Inability to assume or maintain a seated position for the procedure
- Presence of multiple loculations on bedside pre-procedure ultrasound
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study
This randomized controlled trial attempts to determine whether the measurement of pleural pressures during therapeutic thoracentesis affects the development of chest discomfort after the procedure. During thoracentesis, pleural fluid is drained from the pleural space, resulting in lung expansion. In some cases, the lung is not completely re-expandable, in which case continued drainage results in the development of negative pleural pressures and chest discomfort. Negative pleural pressures may also result in other complications such as re-expansion pulmonary edema and pneumothorax. The identification of negative pleural pressures via manometry during the procedure may lead to a reduction in the complication rate.
Read the detailed description
PRIMARY OBJECTIVES:
- To study the impact of pleural manometry on the development of chest discomfort during therapeutic thoracentesis compared to conventional symptom-guided thoracentesis.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo manometry-guided therapeutic thoracentesis.
ARM II: Patients undergo symptom-guided thoracentesis.
- Conditions
- Pleural Effusion
- Being tested
- Manometry-guided thoracentesis, Symptom-guided 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.
Manometry-guided thoracentesisOther
Arm I will undergo a standard of care therapeutic thoracentesis procedure, and in addition include pleural pressure monitoring (via an FDA-approved digital manometer) which is also standard of care but left at the discretion of physicians as per expert recommendations. In this group, the procedure will be stopped when the patient develops symptoms or when all the fluid has been removed, and will also be stopped if the pressure begins to fall quickly in the fluid collection.
Symptom-guided thoracentesisOther
Arm II will undergo a standard of care therapeutic thoracentesis procedure. In this group, the procedure but will be stopped when the patient develops symptoms or when all the fluid has been removed.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Manometry-guided thoracentesis | Experimental | Intervention Group - Patients undergo fine needle- aspiration, called therapeutic thoracentesis, to drain fluid accumulated around the lung. Unlike Arm II, the intervention group will have their pleural pressure monitored during the procedure. Receives: Other: Manometry-guided thoracentesis; Other: Symptom-guided thoracentesis |
| Arm II: Symptom-guided thoracentesis | Active comparator | Comparison Group - Patients undergo symptom-guided thoracentesis, the current standard-of-care is to drain fluid until 1) it is all gone or 2) a symptom occurs that indicates the lung may take longer to fully re-expand and drainage should be stopped. Receives: Other: Symptom-guided 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 (symptom-guided) and intervention (manometry-guided) 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 (8)
Change in chest discomfort scores from pre-procedure to post-procedure.
As measured in millimeters along a 10 cm Visual Analog Scale (VAS). 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: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
Incidence of complete lung re-expansion, as assessed by post-procedure chest radiograph
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)
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
Change in subjective report of dyspnea
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)
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 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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion26 Oct 2017
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt-Ingram Cancer Center
- Investigators
- Fabien Maldonado, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677883
- Sponsor's protocol ID
- VICC THO 1593
- Other IDs
- NCI-2015-02267, P30CA068485
- Status last verified
- Sep 2019
- First submitted
- 18 Jan 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lester M, Maldonado F, Rickman OB, Roller LJ, Avasarala SK, Katsis JM, Lentz RJ. Association between terminal pleural elastance and radiographic lung re-expansion after therapeutic thoracentesis in patients with symptomatic pleural effusion: a post-hoc analysis of a randomised trial. BMJ Open. 2022 Jul 12;12(7):e053606. doi: 10.1136/bmjopen-2021-053606.
PubMed 35820740Lentz RJ, Lerner AD, Pannu JK, Merrick CM, Roller L, Walston C, Valenti S, Goddard T, Chen H, Huggins JT, Rickman OB, Yarmus L, Psallidas I, Rahman NM, Light RW, Maldonado F. Routine monitoring with pleural manometry during therapeutic large-volume thoracentesis to prevent pleural-pressure-related complications: a multicentre, single-blind randomised controlled trial. Lancet Respir Med. 2019 May;7(5):447-455. doi: 10.1016/S2213-2600(18)30421-1. Epub 2019 Feb 13.
PubMed 30772283
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02677883
- Acronym / sponsor ID
- VICC THO 1593
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2016
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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 randomized controlled trial attempts to determine whether the measurement of pleural pressures during therapeutic thoracentesis affects the development of chest discomfort after the procedure. During thoracentesis, pleural fluid is drained from the pleural space, resulting in lung expansion. In some cases, the lung is not completely re-expandable, in which case continued drainage results in the development of negative pleural pressures and chest discomfort. Negative pleural pressures may also result in other complications such as re-expansion pulmonary edema and pneumothorax. The identification of negative pleural pressures via manometry during the procedure may lead to a reduction in the complication rate.
Detailed description
PRIMARY OBJECTIVES:
- To study the impact of pleural manometry on the development of chest discomfort during therapeutic thoracentesis compared to conventional symptom-guided thoracentesis.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo manometry-guided therapeutic thoracentesis.
ARM II: Patients undergo symptom-guided thoracentesis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Manometry-guided thoracentesis | Experimental | Other: Manometry-guided thoracentesis, Other: Symptom-guided thoracentesisIntervention Group - Patients undergo fine needle- aspiration, called therapeutic thoracentesis, to drain fluid accumulated around the lung. Unlike Arm II, the intervention group will have their pleural pressure monitored during the procedure. |
| Arm II: Symptom-guided thoracentesis | Active comparator | Other: Symptom-guided thoracentesisComparison Group - Patients undergo symptom-guided thoracentesis, the current standard-of-care is to drain fluid until 1) it is all gone or 2) a symptom occurs that indicates the lung may take longer to fully re-expand and drainage should be stopped. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referral to pulmonary or interventional radiology services for large-volume thoracentesis
- Presence of a symptomatic moderate or large free-flowing pleural effusion on the basis of:
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
- Manometry felt to be clinically indicated
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 |
|---|---|---|
| Manometry-guided thoracentesisArm I will undergo a standard of care therapeutic thoracentesis procedure, and in addition include pleural pressure monitoring (via an FDA-approved digital manometer) which is also standard of care but left at the discretion of physicians as per expert recommendations. In this group, the procedure will be stopped when the patient develops symptoms or when all the fluid has been removed, and will also be stopped if the pressure begins to fall quickly in the fluid collection. | Other | Arm I: Manometry-guided thoracentesis |
| Symptom-guided thoracentesisArm II will undergo a standard of care therapeutic thoracentesis procedure. In this group, the procedure but will be stopped when the patient develops symptoms or when all the fluid has been removed. | Other | Arm I: Manometry-guided thoracentesis, Arm II: Symptom-guided thoracentesis |
Primary outcome
Difference in post-procedure chest discomfort scores between control (symptom-guided) and intervention (manometry-guided) 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.
8 secondary outcomes
Change in chest discomfort scores from pre-procedure to post-procedure.
Time frame: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
Incidence of complete lung re-expansion, as assessed by post-procedure chest radiograph
Time frame: 20 minutes after thoracentesis catheter is removed (on day 1)
Duration of procedure
Time frame: during the procedure, on day 1, intraoperative
Change in subjective report of dyspnea
Time frame: From 1 minute pre-procedure to 5 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 pneumothorax
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
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 26 Sep 2019.
- Derived from this study: PubMed 35820740Lester M, Maldonado F, Rickman OB, Roller LJ, Avasarala SK, Katsis JM, Lentz RJ. Association between terminal pleural elastance and radiographic lung re-expansion after therapeutic thoracentesis in patients with symptomatic pleural effusion: a post-hoc analysis of a randomised trial. BMJ Open. 2022 Jul 12;12(7):e053606. doi: 10.1136/bmjopen-2021-053606.
- Derived from this study: PubMed 30772283Lentz RJ, Lerner AD, Pannu JK, Merrick CM, Roller L, Walston C, Valenti S, Goddard T, Chen H, Huggins JT, Rickman OB, Yarmus L, Psallidas I, Rahman NM, Light RW, Maldonado F. Routine monitoring with pleural manometry during therapeutic large-volume thoracentesis to prevent pleural-pressure-related complications: a multicentre, single-blind randomised controlled trial. Lancet Respir Med. 2019 May;7(5):447-455. doi: 10.1016/S2213-2600(18)30421-1. Epub 2019 Feb 13.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
Fabien Maldonado principal investigator
Vanderbilt-Ingram 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 Manometry-guided thoracentesis and Symptom-guided thoracentesis in people with Pleural Effusion, run by Vanderbilt-Ingram 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 26 Sep 2019. 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 (symptom-guided) and intervention (manometry-guided) 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 NCT02677883, which also lists 2 linked publications.
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 26 Sep 2019.