<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02975921</url>
  </required_header>
  <id_info>
    <org_study_id>2000020017</org_study_id>
    <nct_id>NCT02975921</nct_id>
  </id_info>
  <brief_title>Betadine Pleurodesis Via Tunneled Pleural Catheters</brief_title>
  <official_title>Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether betadine (povidone-iodine) instillation&#xD;
      during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in&#xD;
      promoting pleurodesis and thus reducing the time to TPC removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting&#xD;
      of recurrent pleural effusions. The most common clinical indication is malignant pleural&#xD;
      effusion but these can be used in benign pleural effusions as well (such as those due to&#xD;
      congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of&#xD;
      dyspnea without the need for recurrent procedures.&#xD;
&#xD;
      Despite success at relieving dyspnea, there are problems with the long-term placement of&#xD;
      TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs&#xD;
      approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a&#xD;
      substantial cost burden. Finally, most patients who undergo TPC placement require home&#xD;
      drainage by visiting nurses. This is a significant resource utilization and it often requires&#xD;
      interruption of a patient's home routines via the visitation requirements.&#xD;
&#xD;
      Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant&#xD;
      effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions.&#xD;
      When pleurodesis occurs, the TPC may be removed by a simple office procedure.&#xD;
&#xD;
      Pleurodesis, or the act of inducing scarring and obliteration of the potential space between&#xD;
      the visceral and parietal pleura where pleural effusions develop, is a different mechanism of&#xD;
      providing relief of dyspnea. In the USA in particular, the most common agent used for&#xD;
      pleurodesis (talc) is associated with complications such as respiratory failure and adult&#xD;
      respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very&#xD;
      expensive.&#xD;
&#xD;
      Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be&#xD;
      highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+%&#xD;
      with Povidone-Iodine. It also has a favorable safety record and is inexpensive.&#xD;
&#xD;
      Given all of these factors, the investigators propose a prospective study using&#xD;
      Povidone-Iodine at the time of TPC placement to promote pleurodesis. The investigators&#xD;
      hypothesize that pleurodesis will occur quickly and frequently, thus enabling removal of the&#xD;
      TPC, thereby saving cost, risks of infection, all while improving patients quality of life.&#xD;
&#xD;
      The investigators plan on doing this by enrolling patients prospectively who are to undergo&#xD;
      TPC placement as part of their standard care. These patients would be prospectively enrolled&#xD;
      and randomized to receive either usual care (no pleurodesis) or the investigational&#xD;
      medication (povidone-iodine) intrapleurally at time of procedure. The investigators would&#xD;
      subdivide groups prospectively between patients who have malignant pleural effusions and&#xD;
      those who have benign (non-malignant) pleural effusions.&#xD;
&#xD;
      Following TPC placement and medication administration (if necessary), nursing and&#xD;
      investigative physicians would then immediately follow them in the recovery area (to monitor&#xD;
      for any negative immediate outcomes such as hypertension, hypotension, reactions, or&#xD;
      significant pain) and in clinic as per their usual care (starting 1-2 weeks after discharge&#xD;
      and as long as necessary). The investigators would monitor them for the outcomes as noted&#xD;
      elsewhere.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The site decided not to proceed with the protocol.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Tunneled Pleural Catheter Removal</measure>
    <time_frame>0-6 months</time_frame>
    <description>The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pleurodesis Rate</measure>
    <time_frame>2 months</time_frame>
    <description>Rate of patients who achieved successful pleurodesis within 2 months as defined as successful TPC removal with no reaccumulation of pleural effusion on subsequent imaging (usually 2-3 weeks later). Typical for usual care is 45-50%. In observational studies using povidone-iodine pleurodesis in other manners (not via TPC), a 90% pleurodesis rate was observed (which should be similar to our study with intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection Rate</measure>
    <time_frame>6 months</time_frame>
    <description>Any skin/site infections or empyemas (pleural based infections) noted within 6 months of TPC placement. The longer a TPC is in place, the higher the rate of infection we would expect. The expected infection rate is between 5-25% at 2 months and this should be dramatically lower in the intervention arm as most of them will have their TPCs removed within 1 week or so.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>6 months</time_frame>
    <description>Any deaths that occur and how long after TPC placement and the patients age at death. As patients are quite systemically ill when they receive TPCs, these comorbidities would be expected to be the primary drivers of patient mortality. Typical values seen in the literature is a mortality rate of 30-70% at 6 months. There should be essentially no difference between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical Complications</measure>
    <time_frame>6 months</time_frame>
    <description>Any mechanical complications related to the TPC itself such as catheter malfunction or accidental removal. This would be a rare complication and the expected rate will be &lt;5%. The incidence of this will rise the longer it is in place for.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Borg Dyspnea Index</measure>
    <time_frame>Baseline</time_frame>
    <description>The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured at baseline prior to Tunneled Pleural Catheter Placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Dyspnea Index at 2 weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 weeks after tunneled pleural catheter placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Dyspnea Index at 2 months</measure>
    <time_frame>2 months</time_frame>
    <description>The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 months after tunneled pleural catheter placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Dyspnea Index at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 4 months after tunneled pleural catheter placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Dyspnea Index at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 6 months after tunneled pleural catheter placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured at baseline prior to the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire at 2 weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 weeks after TPC placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire at 2 months</measure>
    <time_frame>2 months</time_frame>
    <description>Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 months after TPC placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 4 months after TPC placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 6 months after TPC placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Pain</measure>
    <time_frame>Baseline</time_frame>
    <description>Pain at baseline - immediately prior to procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain 2 hours after procedure</measure>
    <time_frame>2 hours after procedure</time_frame>
    <description>Pain at 2 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain 6 hours after procedure</measure>
    <time_frame>6 hours after procedure</time_frame>
    <description>Pain at 6 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate hemodynamic reactions following betadine administration</measure>
    <time_frame>0-6 hours after procedure</time_frame>
    <description>Any severe hemodynamic fluctuations (such as severe hypotension or hypertension) noted after the procedure. The patient will monitored by nursing staff in a recovery area and any events will be noted immediately. The expected rate of this is &lt;5%.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pleural Effusion</condition>
  <condition>Pleurodesis</condition>
  <condition>Malignant Pleural Effusion</condition>
  <condition>Pleural Effusion Due to Congestive Heart Failure</condition>
  <condition>Pleural Effusion in Conditions Classified Elsewhere</condition>
  <condition>Pleural Effusions, Chronic</condition>
  <arm_group>
    <arm_group_label>Malignant Effusion - Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Malignant Effusion with Pleurodesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benign Effusion - Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benign Effusion with Pleurodesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-Iodine</intervention_name>
    <description>Intrapleural administration of Povidone-Iodine</description>
    <arm_group_label>Benign Effusion with Pleurodesis</arm_group_label>
    <arm_group_label>Malignant Effusion with Pleurodesis</arm_group_label>
    <other_name>Betadine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Requiring Tunneled Catheter Placement for a Pleural Effusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a nonexpandable lung&#xD;
&#xD;
          -  Non-english speaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan T Puchalski, MD, MEd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <reference>
    <citation>Agarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy &amp; safety of iodopovidone pleurodesis: a systematic review &amp; meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304.</citation>
    <PMID>22561614</PMID>
  </reference>
  <reference>
    <citation>Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.</citation>
    <PMID>25451360</PMID>
  </reference>
  <reference>
    <citation>Hak CC, Sivakumar P, Ahmed L. Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. BMC Pulm Med. 2016 Mar 11;16:41. doi: 10.1186/s12890-016-0203-7.</citation>
    <PMID>26968653</PMID>
  </reference>
  <reference>
    <citation>Light RW. Pleural effusions. Med Clin North Am. 2011 Nov;95(6):1055-70. doi: 10.1016/j.mcna.2011.08.005. Epub 2011 Sep 25.</citation>
    <PMID>22032427</PMID>
  </reference>
  <reference>
    <citation>Penz ED, Mishra EK, Davies HE, Manns BJ, Miller RF, Rahman NM. Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion. Chest. 2014 Oct;146(4):991-1000. doi: 10.1378/chest.13-2481.</citation>
    <PMID>24832000</PMID>
  </reference>
  <reference>
    <citation>Van Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10.</citation>
    <PMID>20697963</PMID>
  </reference>
  <reference>
    <citation>Walker S, Bibby AC, Maskell NA. Current best practice in the evaluation and management of malignant pleural effusions. Ther Adv Respir Dis. 2017 Feb;11(2):105-114. doi: 10.1177/1753465816671697. Epub 2016 Oct 24.</citation>
    <PMID>27777372</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pleural Effusion</keyword>
  <keyword>Thoracentesis</keyword>
  <keyword>Pleural Cavity</keyword>
  <keyword>Pleurodesis</keyword>
  <keyword>Tunneled Pleural Catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975921
org study id: 2000020017
nct id: NCT02975921
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine whether betadine (povidone-iodine) instillation
      during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in
      promoting pleurodesis and thus reducing the time to TPC removal.
Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting
      of recurrent pleural effusions. The most common clinical indication is malignant pleural
      effusion but these can be used in benign pleural effusions as well (such as those due to
      congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of
      dyspnea without the need for recurrent procedures.

      Despite success at relieving dyspnea, there are problems with the long-term placement of
      TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs
      approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a
      substantial cost burden. Finally, most patients who undergo TPC placement require home
      drainage by visiting nurses. This is a significant resource utilization and it often requires
      interruption of a patient's home routines via the visitation requirements.

      Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant
      effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions.
      When pleurodesis occurs, the TPC may be removed by a simple office procedure.

      Pleurodesis, or the act of inducing scarring and obliteration of the potential space between
      the visceral and parietal pleura where pleural effusions develop, is a different mechanism of
      providing relief of dyspnea. In the USA in particular, the most common agent used for
      pleurodesis (talc) is associated with complications such as respiratory failure and adult
      respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very
      expensive.

      Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be
      highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+%
      with Povidone-Iodine. It also has a favorable safety record and is inexpensive.

      Given all of these factors, the investigators propose a prospective study using
      Povidone-Iodine at the time of TPC placement to promote pleurodesis. The investigators
      hypothesize that pleurodesis will occur quickly and frequently, thus enabling removal of the
      TPC, thereby saving cost, risks of infection, all while improving patients quality of life.

      The investigators plan on doing this by enrolling patients prospectively who are to undergo
      TPC placement as part of their standard care. These patients would be prospectively enrolled
      and randomized to receive either usual care (no pleurodesis) or the investigational
      medication (povidone-iodine) intrapleurally at time of procedure. The investigators would
      subdivide groups prospectively between patients who have malignant pleural effusions and
      those who have benign (non-malignant) pleural effusions.

      Following TPC placement and medication administration (if necessary), nursing and
      investigative physicians would then immediately follow them in the recovery area (to monitor
      for any negative immediate outcomes such as hypertension, hypotension, reactions, or
      significant pain) and in clinic as per their usual care (starting 1-2 weeks after discharge
      and as long as necessary). The investigators would monitor them for the outcomes as noted
      elsewhere.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to Tunneled Pleural Catheter Removal
time frame: 0-6 months
description: The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months
measure: Pleurodesis Rate
time frame: 2 months
description: Rate of patients who achieved successful pleurodesis within 2 months as defined as successful TPC removal with no reaccumulation of pleural effusion on subsequent imaging (usually 2-3 weeks later). Typical for usual care is 45-50%. In observational studies using povidone-iodine pleurodesis in other manners (not via TPC), a 90% pleurodesis rate was observed (which should be similar to our study with intervention).
measure: Infection Rate
time frame: 6 months
description: Any skin/site infections or empyemas (pleural based infections) noted within 6 months of TPC placement. The longer a TPC is in place, the higher the rate of infection we would expect. The expected infection rate is between 5-25% at 2 months and this should be dramatically lower in the intervention arm as most of them will have their TPCs removed within 1 week or so.
measure: Death
time frame: 6 months
description: Any deaths that occur and how long after TPC placement and the patients age at death. As patients are quite systemically ill when they receive TPCs, these comorbidities would be expected to be the primary drivers of patient mortality. Typical values seen in the literature is a mortality rate of 30-70% at 6 months. There should be essentially no difference between groups.
measure: Mechanical Complications
time frame: 6 months
description: Any mechanical complications related to the TPC itself such as catheter malfunction or accidental removal. This would be a rare complication and the expected rate will be <5%. The incidence of this will rise the longer it is in place for.
measure: Baseline Borg Dyspnea Index
time frame: Baseline
description: The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured at baseline prior to Tunneled Pleural Catheter Placement.
measure: Borg Dyspnea Index at 2 weeks
time frame: 2 weeks
description: The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 weeks after tunneled pleural catheter placement.
measure: Borg Dyspnea Index at 2 months
time frame: 2 months
description: The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 months after tunneled pleural catheter placement.
measure: Borg Dyspnea Index at 4 months
time frame: 4 months
description: The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 4 months after tunneled pleural catheter placement.
measure: Borg Dyspnea Index at 6 months
time frame: 6 months
description: The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 6 months after tunneled pleural catheter placement.
measure: Quality of Life Questionnaire at Baseline
time frame: Baseline
description: Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured at baseline prior to the procedure.
measure: Quality of Life Questionnaire at 2 weeks
time frame: 2 weeks
description: Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 weeks after TPC placement.
measure: Quality of Life Questionnaire at 2 months
time frame: 2 months
description: Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 months after TPC placement.
measure: Quality of Life Questionnaire at 4 months
time frame: 4 months
description: Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 4 months after TPC placement.
measure: Quality of Life Questionnaire at 6 months
time frame: 6 months
description: Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 6 months after TPC placement.
measure: Baseline Pain
time frame: Baseline
description: Pain at baseline - immediately prior to procedure.
measure: Pain 2 hours after procedure
time frame: 2 hours after procedure
description: Pain at 2 hours after the procedure.
measure: Pain 6 hours after procedure
time frame: 6 hours after procedure
description: Pain at 6 hours after the procedure.
measure: Immediate hemodynamic reactions following betadine administration
time frame: 0-6 hours after procedure
description: Any severe hemodynamic fluctuations (such as severe hypotension or hypertension) noted after the procedure. The patient will monitored by nursing staff in a recovery area and any events will be noted immediately. The expected rate of this is <5%.
arm group label: Malignant Effusion - Usual Care
arm group type: No Intervention
description: Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.
arm group label: Malignant Effusion with Pleurodesis
arm group type: Experimental
description: Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
arm group label: Benign Effusion - Usual Care
arm group type: No Intervention
description: Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.
arm group label: Benign Effusion with Pleurodesis
arm group type: Experimental
description: Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
intervention type: Drug
intervention name: Povidone-Iodine
description: Intrapleural administration of Povidone-Iodine
arm group label: Benign Effusion with Pleurodesis
arm group label: Malignant Effusion with Pleurodesis
other name: Betadine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan T Puchalski, MD, MEd
role: Principal Investigator
affiliation: Yale University
citation: Agarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304.
PMID: 22561614
citation: Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.
PMID: 25451360
citation: Hak CC, Sivakumar P, Ahmed L. Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. BMC Pulm Med. 2016 Mar 11;16:41. doi: 10.1186/s12890-016-0203-7.
PMID: 26968653
citation: Light RW. Pleural effusions. Med Clin North Am. 2011 Nov;95(6):1055-70. doi: 10.1016/j.mcna.2011.08.005. Epub 2011 Sep 25.
PMID: 22032427
citation: Penz ED, Mishra EK, Davies HE, Manns BJ, Miller RF, Rahman NM. Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion. Chest. 2014 Oct;146(4):991-1000. doi: 10.1378/chest.13-2481.
PMID: 24832000
citation: Van Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10.
PMID: 20697963
citation: Walker S, Bibby AC, Maskell NA. Current best practice in the evaluation and management of malignant pleural effusions. Ther Adv Respir Dis. 2017 Feb;11(2):105-114. doi: 10.1177/1753465816671697. Epub 2016 Oct 24.
PMID: 27777372
responsible party type: Sponsor
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion
mesh term: Heart Failure
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: No