Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

NCT02677883 | Completed DMC

• 3 other identifiers: VICC THO 1593NCI-2015-02267P30CA068485
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Difference in post-procedure chest discomfort scores between control (symptom-guided) and intervention (manometry-guided) groups

  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.

  one-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)

Secondary Outcomes (8)

• 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)

• Incidence of complete lung re-expansion, as assessed by post-procedure chest radiograph

  20 minutes after thoracentesis catheter is removed (on day 1)

• Duration of procedure

  during the procedure, on day 1, intraoperative

• Change in subjective report of dyspnea

  From 1 minute pre-procedure to 5 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)

Other Outcomes (1)

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

  at time of procedure

Study Arms (2)

Arm I: Manometry-guided thoracentesis

EXPERIMENTAL

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; Other: Symptom-guided thoracentesis

Arm II: Symptom-guided thoracentesis

ACTIVE COMPARATOR

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

Interventions

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.

Arm I: Manometry-guided thoracentesis

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.

Arm I: Manometry-guided thoracentesis; Arm II: Symptom-guided thoracentesis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• 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.

  PMID: 35820740 DERIVED

• 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.

  PMID: 30772283 DERIVED

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Fabien Maldonado

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 9, 2016
• Study Start: January 1, 2016
• Primary Completion: October 26, 2017
• Study Completion: March 8, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)