- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02677883
Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis
Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I: Manometry-guided thoracentesis
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.
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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.
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.
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Active Comparator: Arm II: Symptom-guided thoracentesis
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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one-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of pneumothorax
Time Frame: 20 minutes after thoracentesis catheter is removed (on day 1)
|
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.
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20 minutes after thoracentesis catheter is removed (on day 1)
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Incidence of clinically-significant re-expansion pulmonary edema
Time Frame: 20 minutes after thoracentesis catheter is removed (on day 1)
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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.
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20 minutes after thoracentesis catheter is removed (on day 1)
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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)
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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.
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From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
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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)
|
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.
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20 minutes after thoracentesis catheter is removed (on day 1)
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Duration of procedure
Time Frame: during the procedure, on day 1, intraoperative
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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.
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during the procedure, on day 1, intraoperative
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Change in subjective report of dyspnea
Time Frame: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
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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.
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From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
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Incidence of radiographically-apparent re-expansion pulmonary edema
Time Frame: 20 minutes after thoracentesis catheter is removed (on day 1)
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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
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20 minutes after thoracentesis catheter is removed (on day 1)
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Volume of pleural fluid removed by the thoracentesis procedure
Time Frame: immediately after the thoracentesis catheter is removed, on day 1
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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.
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immediately after the thoracentesis catheter is removed, on day 1
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Trend in VAS pain scores up to the point at which 1.5L of fluid is removed
Time Frame: at time of procedure
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at time of procedure
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fabien Maldonado, Vanderbilt-Ingram Cancer Center
Publications and helpful links
General 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.
- Lentz 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC THO 1593
- P30CA068485 (U.S. NIH Grant/Contract)
- NCI-2015-02267 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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