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Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

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ClinicalTrials.gov Identifier: NCT02677883
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fabien Maldonado, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Other: Manometry-guided thoracentesis Other: Symptom-guided thoracentesis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study
Study Start Date : January 2016
Actual Primary Completion Date : October 26, 2017
Estimated Study Completion Date : December 2019

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.
Other: Manometry-guided thoracentesis
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.

Other: Symptom-guided thoracentesis
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.

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.
Other: Symptom-guided thoracentesis
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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.

  3. Duration of procedure [ Time Frame: during the procedure, on day 1, intraoperative ]
    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.

  4. Change in subjective report of dyspnea [ Time Frame: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1) ]
    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.

  5. Incidence of clinically-significant re-expansion pulmonary edema [ Time Frame: 20 minutes after thoracentesis catheter is removed (on day 1) ]
    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.

  6. 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.

  7. Incidence of radiographically-apparent re-expansion pulmonary edema [ Time Frame: 20 minutes after thoracentesis catheter is removed (on day 1) ]
    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

  8. Volume of pleural fluid removed by the thoracentesis procedure [ Time Frame: immediately after the thoracentesis catheter is removed, on day 1 ]
    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.


Other Outcome Measures:
  1. 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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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677883


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Fabien Maldonado Vanderbilt-Ingram Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabien Maldonado, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02677883     History of Changes
Other Study ID Numbers: VICC THO 1593
NCI-2015-02267 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases