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Completed

NCT Number: NCT02677883

Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

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.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manometry-guided thoracentesis

Other

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 thoracentesis

Other

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 outcomes

  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 outcomes

  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 outcomes

  1. Trend in VAS pain scores up to the point at which 1.5L of fluid is removed

    Time frame: at time of procedure

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Feb 9, 2016
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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