Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-03-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Manometry-guided thoracentesis

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Symptom-guided thoracentesis

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No