<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/NCT04413695</url>
  </required_header>
  <id_info>
    <org_study_id>ILBSIndia 2</org_study_id>
    <nct_id>NCT04413695</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound as a Point of Care Test for Living Donor Liver Transplant Recipients.</brief_title>
  <official_title>Lung Ultrasound as a Point of Care Test for Living Donor Liver Transplant Recipients: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary&#xD;
      complications are common in the perioperative period and are associated with adverse&#xD;
      outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and&#xD;
      collapse. Risk factors for the same are extensive surgery, transfusion of blood products,&#xD;
      fluid overload, hemodynamic instability, coagulation abnormalities, renal dysfunction, and&#xD;
      reperfusion syndrome. CXR with clinical judgment plays a key role in diagnosing pulmonary&#xD;
      complications. However diagnostic ability of CXR is limited and moreover it is associated&#xD;
      with unnecessary radiation exposure. Recently, lung USG has come up as an easily available&#xD;
      tool to detect peri-op pulmonary complications. The technique is very easy to perform, less&#xD;
      time-consuming, and totally cost-effective. Moreover, it can be easily learned by clinicians&#xD;
      with a standard level of ability to handle an ultrasound probe for abdominal scans. In the&#xD;
      setting of geriatric and ICU patients, fragility and immobility have a strong impact on the&#xD;
      quality of a chest radiograph. So, the routine application of lung USG in this setting may&#xD;
      significantly improve the outcome. Multiple studies have suggested that Lung USG is superior&#xD;
      to CXR in diagnosing these lung conditions. Hence, this study aims to compare the lung&#xD;
      ultrasound with CXR in detecting perioperative pulmonary complications in patients undergoing&#xD;
      live donor liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study on liver transplant recipient patients, until&#xD;
      postoperative day seven. After approval of the ethical committee and written informed&#xD;
      consent, all liver transplant recipients meeting inclusion criteria are enrolled in the&#xD;
      study. Patient characteristics like the cause of liver failure, CTP scoring, MELD Na scoring,&#xD;
      graft vs recipient weight ratio, age, weight, height, BMI, pulmonary and other comorbidities&#xD;
      are noted. Both lung ultrasound and CXR are done simultaneously in all patients on: one day&#xD;
      prior to surgery and post-operatively from day 1 to day 7. Ultrasound is done by an&#xD;
      experienced anesthesiologist with good experience in lung ultrasound, while the CXR was&#xD;
      interpreted by the another physician. Based on the findings in the different regions of the&#xD;
      thorax, a lung ultrasound score (LUS) is calculated as the following:- Each hemithorax is&#xD;
      divided into anterior-lateral sectors (from parasternal to posterior axillary lines) and&#xD;
      posterior sectors (from posterior axillary to paravertebral line). Each sector then divided&#xD;
      into upper and lower halves taking the third intercostal space as reference, so that 4 areas&#xD;
      could be finally identified for each hemithorax. The probe was set perpendicular, oblique,&#xD;
      and parallel to the ribs to assess the degree of lung aeration with a total of 8 zones to be&#xD;
      examined using a linear and convex probe. Image interpretation will be according to Lung&#xD;
      Ultrasound Score. Lung ultrasound score varies from 0-3 [0 = normal aeration; 1 = moderate&#xD;
      loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized&#xD;
      pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space&#xD;
      examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration&#xD;
      (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal&#xD;
      space); 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern&#xD;
      with or without air bronchogram)]. The LUS is calculated as the sum of the 12 regional&#xD;
      scores. Along with the LUS, other complications like atelectasis, pulmonary edema,&#xD;
      consolidation, effusion and collapse are also noted. The LUS will be correlated with&#xD;
      clinically relevant perioperative pulmonary complications (POPC) and the length of the ICU&#xD;
      stay. The clinically relevant POPC are defined when any of the following present:&#xD;
&#xD;
      1.Increase in RR &gt;25/min 2. The need of FIO2&gt;10% 3. Increase Need of PS by 5cm of H2O and&#xD;
      need of PEEP by 2cm of H20 4.The need of IMV, reinitiation of NIV, and insertion of ICD. Both&#xD;
      CXR and lung ultrasound findings are compared with respect to the day of appearance of&#xD;
      complications on CXR and ultrasound. In addition the data will be collected for the total&#xD;
      duration of the complication, total length of icu and hospital stay.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Anticipated">September 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 25, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray</measure>
    <time_frame>till post operative seventh day</time_frame>
    <description>Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)</measure>
    <time_frame>First post-operative seven days</time_frame>
    <description>Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay</measure>
    <time_frame>First post-operative seven days</time_frame>
    <description>Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Liver Transplant; Complications</condition>
  <eligibility>
    <study_pop>
      <textblock>
        End stage liver disease patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 18 to 65yrs All end stage liver disease patients undergoing live donor liver&#xD;
        transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients not giving consent for enrollment Any structural cardiac condition Dead donor&#xD;
        liver transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gaurav sindwani, md</last_name>
    <role>Study Chair</role>
    <affiliation>ilbs</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>gaurav sindwani, md</last_name>
    <phone>08728089898</phone>
    <email>drsindwani25@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gaurav Sindwani</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>gaurav sindwani, md</last_name>
      <phone>08728089898</phone>
      <email>drsindwani25@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Feltracco P, Carollo C, Barbieri S, Pettenuzzo T, Ori C. Early respiratory complications after liver transplantation. World J Gastroenterol. 2013 Dec 28;19(48):9271-81. doi: 10.3748/wjg.v19.i48.9271.</citation>
    <PMID>24409054</PMID>
  </reference>
  <reference>
    <citation>Ruchonnet-Metrailler I, Blanchon S, Luthold S, Wildhaber BE, Rimensberger PC, Barazzone-Argiroffo C, Mc Lin VA. Pulmonary complications after liver transplantation in children: risk factors and impact on early post-operative morbidity. Pediatr Transplant. 2018 Jul 17:e13243. doi: 10.1111/petr.13243. Online ahead of print.</citation>
    <PMID>30019517</PMID>
  </reference>
  <reference>
    <citation>Tierney DM, Boland LL, Overgaard JD, Huelster JS, Jorgenson A, Normington JP, Melamed RR. Pulmonary ultrasound scoring system for intubated critically ill patients and its association with clinical metrics and mortality: A prospective cohort study. J Clin Ultrasound. 2018 Jan;46(1):14-22. doi: 10.1002/jcu.22526. Epub 2017 Oct 6.</citation>
    <PMID>28984373</PMID>
  </reference>
  <reference>
    <citation>Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.</citation>
    <PMID>26298866</PMID>
  </reference>
  <results_reference>
    <citation>Yin W, Zou T, Qin Y, Yang J, Li Y, Zeng X, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Poor lung ultrasound score in shock patients admitted to the ICU is associated with worse outcome. BMC Pulm Med. 2019 Jan 3;19(1):1. doi: 10.1186/s12890-018-0755-9.</citation>
    <PMID>30606165</PMID>
  </results_reference>
  <results_reference>
    <citation>Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.</citation>
    <PMID>22584759</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Liver and Biliary Sciences, India</investigator_affiliation>
    <investigator_full_name>Gaurav Sindwani</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>liver transplant</keyword>
  <keyword>lung ultrasound</keyword>
  <keyword>chest x ray</keyword>
  <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/NCT04413695
org study id: ILBSIndia 2
nct id: NCT04413695
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary
      complications are common in the perioperative period and are associated with adverse
      outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and
      collapse. Risk factors for the same are extensive surgery, transfusion of blood products,
      fluid overload, hemodynamic instability, coagulation abnormalities, renal dysfunction, and
      reperfusion syndrome. CXR with clinical judgment plays a key role in diagnosing pulmonary
      complications. However diagnostic ability of CXR is limited and moreover it is associated
      with unnecessary radiation exposure. Recently, lung USG has come up as an easily available
      tool to detect peri-op pulmonary complications. The technique is very easy to perform, less
      time-consuming, and totally cost-effective. Moreover, it can be easily learned by clinicians
      with a standard level of ability to handle an ultrasound probe for abdominal scans. In the
      setting of geriatric and ICU patients, fragility and immobility have a strong impact on the
      quality of a chest radiograph. So, the routine application of lung USG in this setting may
      significantly improve the outcome. Multiple studies have suggested that Lung USG is superior
      to CXR in diagnosing these lung conditions. Hence, this study aims to compare the lung
      ultrasound with CXR in detecting perioperative pulmonary complications in patients undergoing
      live donor liver transplantation.
This is a prospective observational study on liver transplant recipient patients, until
      postoperative day seven. After approval of the ethical committee and written informed
      consent, all liver transplant recipients meeting inclusion criteria are enrolled in the
      study. Patient characteristics like the cause of liver failure, CTP scoring, MELD Na scoring,
      graft vs recipient weight ratio, age, weight, height, BMI, pulmonary and other comorbidities
      are noted. Both lung ultrasound and CXR are done simultaneously in all patients on: one day
      prior to surgery and post-operatively from day 1 to day 7. Ultrasound is done by an
      experienced anesthesiologist with good experience in lung ultrasound, while the CXR was
      interpreted by the another physician. Based on the findings in the different regions of the
      thorax, a lung ultrasound score (LUS) is calculated as the following:- Each hemithorax is
      divided into anterior-lateral sectors (from parasternal to posterior axillary lines) and
      posterior sectors (from posterior axillary to paravertebral line). Each sector then divided
      into upper and lower halves taking the third intercostal space as reference, so that 4 areas
      could be finally identified for each hemithorax. The probe was set perpendicular, oblique,
      and parallel to the ribs to assess the degree of lung aeration with a total of 8 zones to be
      examined using a linear and convex probe. Image interpretation will be according to Lung
      Ultrasound Score. Lung ultrasound score varies from 0-3 [0 = normal aeration; 1 = moderate
      loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized
      pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space
      examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration
      (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal
      space); 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern
      with or without air bronchogram)]. The LUS is calculated as the sum of the 12 regional
      scores. Along with the LUS, other complications like atelectasis, pulmonary edema,
      consolidation, effusion and collapse are also noted. The LUS will be correlated with
      clinically relevant perioperative pulmonary complications (POPC) and the length of the ICU
      stay. The clinically relevant POPC are defined when any of the following present:

      1.Increase in RR >25/min 2. The need of FIO2>10% 3. Increase Need of PS by 5cm of H2O and
      need of PEEP by 2cm of H20 4.The need of IMV, reinitiation of NIV, and insertion of ICD. Both
      CXR and lung ultrasound findings are compared with respect to the day of appearance of
      complications on CXR and ultrasound. In addition the data will be collected for the total
      duration of the complication, total length of icu and hospital stay.

      .
observational model: Case-Control
time perspective: Prospective
measure: Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray
time frame: till post operative seventh day
description: Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray
measure: Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)
time frame: First post-operative seven days
description: Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)
measure: Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay
time frame: First post-operative seven days
description: Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: gaurav sindwani, md
role: Study Chair
affiliation: ilbs
last name: gaurav sindwani, md
phone: 08728089898
email: drsindwani25@gmail.com
facility: 
status: Recruiting
contact: 
country: India
citation: Feltracco P, Carollo C, Barbieri S, Pettenuzzo T, Ori C. Early respiratory complications after liver transplantation. World J Gastroenterol. 2013 Dec 28;19(48):9271-81. doi: 10.3748/wjg.v19.i48.9271.
PMID: 24409054
citation: Ruchonnet-Metrailler I, Blanchon S, Luthold S, Wildhaber BE, Rimensberger PC, Barazzone-Argiroffo C, Mc Lin VA. Pulmonary complications after liver transplantation in children: risk factors and impact on early post-operative morbidity. Pediatr Transplant. 2018 Jul 17:e13243. doi: 10.1111/petr.13243. Online ahead of print.
PMID: 30019517
citation: Tierney DM, Boland LL, Overgaard JD, Huelster JS, Jorgenson A, Normington JP, Melamed RR. Pulmonary ultrasound scoring system for intubated critically ill patients and its association with clinical metrics and mortality: A prospective cohort study. J Clin Ultrasound. 2018 Jan;46(1):14-22. doi: 10.1002/jcu.22526. Epub 2017 Oct 6.
PMID: 28984373
citation: Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
PMID: 26298866
citation: Yin W, Zou T, Qin Y, Yang J, Li Y, Zeng X, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Poor lung ultrasound score in shock patients admitted to the ICU is associated with worse outcome. BMC Pulm Med. 2019 Jan 3;19(1):1. doi: 10.1186/s12890-018-0755-9.
PMID: 30606165
citation: Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
PMID: 22584759
responsible party type: Principal Investigator
investigator affiliation: Institute of Liver and Biliary Sciences, India
investigator full name: Gaurav Sindwani
investigator title: Assistant Professor
sharing ipd: No