Manometry- Versus Symptom-Guided Large Volume Thoracentesis: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Difference in post-procedure chest discomfort scores between control (symptom-guided) and intervention (manometry-guided) groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Manometry-guided thoracentesis (Other)
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.
Intervention: Symptom-guided thoracentesis (Other)
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.
Intervention: Symptom-guided thoracentesis (Other)
Outcomes
Primary Outcomes
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
- Incidence of complete lung re-expansion, as assessed by post-procedure chest radiograph(20 minutes after thoracentesis catheter is removed (on day 1))
- Incidence of pneumothorax(20 minutes after thoracentesis catheter is removed (on day 1))
- Duration of procedure(during the procedure, on day 1, intraoperative)
- Volume of pleural fluid removed by the thoracentesis procedure(immediately after the thoracentesis catheter is removed, on day 1)
- Change in chest discomfort scores from pre-procedure to post-procedure.(From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1))
- Change in subjective report of dyspnea(From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1))
- Incidence of radiographically-apparent re-expansion pulmonary edema(20 minutes after thoracentesis catheter is removed (on day 1))
- Incidence of clinically-significant re-expansion pulmonary edema(20 minutes after thoracentesis catheter is removed (on day 1))
Investigators
Fabien Maldonado
Principal Investigator
Vanderbilt-Ingram Cancer Center