Clinical trial NCT02677883: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-02-09
Enrollment: 89
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference in post-procedure chest discomfort scores between control (symptom-guided) and intervention (manometry-guided) groups
timeFrame: one-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)
Secondary outcomes:
measure: Change in chest discomfort scores from pre-procedure to post-procedure.
timeFrame: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
measure: Incidence of complete lung re-expansion, as assessed by post-procedure chest radiograph
timeFrame: 20 minutes after thoracentesis catheter is removed (on day 1)
measure: Duration of procedure
timeFrame: during the procedure, on day 1, intraoperative
measure: Change in subjective report of dyspnea
timeFrame: From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)
measure: Incidence of clinically-significant re-expansion pulmonary edema
timeFrame: 20 minutes after thoracentesis catheter is removed (on day 1)
measure: Incidence of pneumothorax
timeFrame: 20 minutes after thoracentesis catheter is removed (on day 1)
measure: Incidence of radiographically-apparent re-expansion pulmonary edema
timeFrame: 20 minutes after thoracentesis catheter is removed (on day 1)
measure: Volume of pleural fluid removed by the thoracentesis procedure
timeFrame: immediately after the thoracentesis catheter is removed, on day 1
Other outcomes:
measure: Trend in VAS pain scores up to the point at which 1.5L of fluid is removed
timeFrame: at time of procedure
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Fabien Maldonado
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.