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Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

Primary Purpose

Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manometry-guided thoracentesis
Symptom-guided thoracentesis
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pleural Effusion

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I: Manometry-guided thoracentesis

Arm II: Symptom-guided thoracentesis

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
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.

Full Information

First Posted
January 18, 2016
Last Updated
September 24, 2019
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02677883
Brief Title
Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis
Official Title
Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: Manometry-guided thoracentesis
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II: Symptom-guided thoracentesis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manometry-guided thoracentesis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Symptom-guided thoracentesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in post-procedure chest discomfort scores between control (symptom-guided) and intervention (manometry-guided) groups
Description
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.
Time Frame
one-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)
Secondary Outcome Measure Information:
Title
Change in chest discomfort scores from pre-procedure to post-procedure.
Description
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.
Time Frame
From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
Title
Incidence of complete lung re-expansion, as assessed by post-procedure chest radiograph
Description
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.
Time Frame
20 minutes after thoracentesis catheter is removed (on day 1)
Title
Duration of procedure
Description
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.
Time Frame
during the procedure, on day 1, intraoperative
Title
Change in subjective report of dyspnea
Description
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.
Time Frame
From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
Title
Incidence of clinically-significant re-expansion pulmonary edema
Description
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.
Time Frame
20 minutes after thoracentesis catheter is removed (on day 1)
Title
Incidence of pneumothorax
Description
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.
Time Frame
20 minutes after thoracentesis catheter is removed (on day 1)
Title
Incidence of radiographically-apparent re-expansion pulmonary edema
Description
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
Time Frame
20 minutes after thoracentesis catheter is removed (on day 1)
Title
Volume of pleural fluid removed by the thoracentesis procedure
Description
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.
Time Frame
immediately after the thoracentesis catheter is removed, on day 1
Other Pre-specified Outcome Measures:
Title
Trend in VAS pain scores up to the point at which 1.5L of fluid is removed
Time Frame
at time of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Maldonado
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35820740
Citation
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.
Results Reference
derived
PubMed Identifier
30772283
Citation
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.
Results Reference
derived
Links:
URL
http://vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

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Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

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