<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/NCT03828630</url>
  </required_header>
  <id_info>
    <org_study_id>LUSIP</org_study_id>
    <nct_id>NCT03828630</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients</brief_title>
  <acronym>LUSIP</acronym>
  <official_title>Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients in an Urban Low-Resource Setting (LUSIP) - an Observational Study in Sierra Leone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol Oxford Tropical Medicine Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sierra Leone</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Doctors with Africa - CUAMM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bari</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims at describing the frequency, timing and type of pulmonary complications&#xD;
      detected with lung ultrasound in critically-ill parturients in admitted to a high-dependency&#xD;
      unit in Freetown, Sierra Leone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: The three big 'killers' in parturients, peripartum hemorrhage, sepsis and&#xD;
      pre-eclampsia all predispose to pulmonary complications. These complications affect&#xD;
      management before, during and after the primary obstetric problem has been solved. A timely&#xD;
      diagnosis and thorough follow-up of pulmonary complications may benefit parturients. Lung&#xD;
      ultrasound (LUS) is a point-of-care imaging bedside tool increasingly used in the critical&#xD;
      care setting that may prove useful in parturients.&#xD;
&#xD;
      Objective: To describe frequency, timing and type of pulmonary complications detected with&#xD;
      LUS in critically ill parturients in a high-dependency unit (HDU), and to determine the&#xD;
      association with outcome.&#xD;
&#xD;
      Hypotheses: Pulmonary complications detected by LUS are frequent in parturients admitted to a&#xD;
      HDU in a resource-limited setting, and are associated with hospital mortality.&#xD;
&#xD;
      Study design: A prospective observational study. Study population: Critically ill parturients&#xD;
      admitted to the HDU of the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra&#xD;
      Leone.&#xD;
&#xD;
      Sample size: No formal sample size calculation is performed. Based on current rates of&#xD;
      admissions to the HDU of the PCMH the investigators expect to perform LUS in at least 125&#xD;
      patients.&#xD;
&#xD;
      Methods: A trained physician performs all 12-region LUS investigations. LUS is performed at&#xD;
      admission, after 24 and 48 hours, and when a patient's respiratory condition deteriorates.&#xD;
      LUS findings are reported using a standardized semi-quantitative visual LUS scoring method.&#xD;
&#xD;
      Main study parameters/primary endpoints: The proportion of critically ill parturients&#xD;
      admitted to the HDU of the PCMH with pulmonary complications detected by LUS, including&#xD;
      interstitial syndrome, pulmonary consolidation, and pleural effusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2018</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 27, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of parturients with pulmonary complications</measure>
    <time_frame>From admission to 48 hours later</time_frame>
    <description>proportion of parturients with pulmonary complications detected by LUS during stay in the HDU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of lung ultrasound findings</measure>
    <time_frame>From admission to 48 hours later</time_frame>
    <description>Precise description of ultrasound findings (proportion of patients with a normal lung, interstitial syndrome, lung consolidation, pleural effusion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of diagnoses made with lung ultrasound</measure>
    <time_frame>From admission to 48 hours later</time_frame>
    <description>Proportion of patients with a diagnosis of pneumonia, acute respiratory distress syndrome, fluid overload, no pulmonary complication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative risk of death in patients with a pulmonary complication</measure>
    <time_frame>On the day of HDU discharge or death, whichever came first, assessed up to 12 weeks after enrollment</time_frame>
    <description>Risk of death in the group with pulmonary complication divided by the risk of death in parturients without a pulmonary complication</description>
  </secondary_outcome>
  <enrollment type="Actual">168</enrollment>
  <condition>Obstetric Complication</condition>
  <condition>Lung Injury, Acute</condition>
  <condition>Pulmonary Disease</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill parturients admitted to the HDU of the Princess Christian Maternity Hospital&#xD;
        (PCMH) in Freetown, Sierra Leone.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to the HDU of the PCMH during the study period&#xD;
&#xD;
          -  Verbal informed consent of the patient or his/her formal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lung ultrasound not feasible, e.g., due to electricity breakdown, or absence of the&#xD;
             trained sonographer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcella Schiavone, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Doctors with Africa - CUAMM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna de Nicolo, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Bari</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eva Henciles, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sierra Leone</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcus J Schultz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Amsterdam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Christian Maternity Hospital</name>
      <address>
        <city>Freetown</city>
        <country>Sierra Leone</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sierra Leone</country>
  </location_countries>
  <reference>
    <citation>Leopold SJ, Ghose A, Plewes KA, Mazumder S, Pisani L, Kingston HWF, Paul S, Barua A, Sattar MA, Huson MAM, Walden AP, Henwood PC, Riviello ED, Schultz MJ, Day NPJ, Kumar Dutta A, White NJ, Dondorp AM. Point-of-care lung ultrasound for the detection of pulmonary manifestations of malaria and sepsis: An observational study. PLoS One. 2018 Dec 12;13(12):e0204832. doi: 10.1371/journal.pone.0204832. eCollection 2018.</citation>
    <PMID>30540757</PMID>
  </reference>
  <reference>
    <citation>Vercesi V, Pisani L, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MMA, Henwood PC, Walden A, Smit M, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. External confirmation and exploration of the Kigali modification for diagnosing moderate or severe ARDS. Intensive Care Med. 2018 Apr;44(4):523-524. doi: 10.1007/s00134-018-5048-5. Epub 2018 Jan 24. No abstract available. Erratum In: Intensive Care Med. 2018 Feb 20;:</citation>
    <PMID>29368056</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 24, 2019</last_update_submitted>
  <last_update_submitted_qc>April 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Marcus J. Schultz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03828630
org study id: LUSIP
nct id: NCT03828630
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims at describing the frequency, timing and type of pulmonary complications
      detected with lung ultrasound in critically-ill parturients in admitted to a high-dependency
      unit in Freetown, Sierra Leone.
Rationale: The three big 'killers' in parturients, peripartum hemorrhage, sepsis and
      pre-eclampsia all predispose to pulmonary complications. These complications affect
      management before, during and after the primary obstetric problem has been solved. A timely
      diagnosis and thorough follow-up of pulmonary complications may benefit parturients. Lung
      ultrasound (LUS) is a point-of-care imaging bedside tool increasingly used in the critical
      care setting that may prove useful in parturients.

      Objective: To describe frequency, timing and type of pulmonary complications detected with
      LUS in critically ill parturients in a high-dependency unit (HDU), and to determine the
      association with outcome.

      Hypotheses: Pulmonary complications detected by LUS are frequent in parturients admitted to a
      HDU in a resource-limited setting, and are associated with hospital mortality.

      Study design: A prospective observational study. Study population: Critically ill parturients
      admitted to the HDU of the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra
      Leone.

      Sample size: No formal sample size calculation is performed. Based on current rates of
      admissions to the HDU of the PCMH the investigators expect to perform LUS in at least 125
      patients.

      Methods: A trained physician performs all 12-region LUS investigations. LUS is performed at
      admission, after 24 and 48 hours, and when a patient's respiratory condition deteriorates.
      LUS findings are reported using a standardized semi-quantitative visual LUS scoring method.

      Main study parameters/primary endpoints: The proportion of critically ill parturients
      admitted to the HDU of the PCMH with pulmonary complications detected by LUS, including
      interstitial syndrome, pulmonary consolidation, and pleural effusion.
observational model: Cohort
time perspective: Prospective
measure: Proportion of parturients with pulmonary complications
time frame: From admission to 48 hours later
description: proportion of parturients with pulmonary complications detected by LUS during stay in the HDU.
measure: Description of lung ultrasound findings
time frame: From admission to 48 hours later
description: Precise description of ultrasound findings (proportion of patients with a normal lung, interstitial syndrome, lung consolidation, pleural effusion)
measure: Description of diagnoses made with lung ultrasound
time frame: From admission to 48 hours later
description: Proportion of patients with a diagnosis of pneumonia, acute respiratory distress syndrome, fluid overload, no pulmonary complication.
measure: Relative risk of death in patients with a pulmonary complication
time frame: On the day of HDU discharge or death, whichever came first, assessed up to 12 weeks after enrollment
description: Risk of death in the group with pulmonary complication divided by the risk of death in parturients without a pulmonary complication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marcella Schiavone, MD, PhD
role: Study Chair
affiliation: Doctors with Africa - CUAMM
last name: Anna de Nicolo, MD, PhD
role: Study Chair
affiliation: University of Bari
last name: Eva Henciles, MD
role: Principal Investigator
affiliation: University of Sierra Leone
last name: Marcus J Schultz, MD, PhD
role: Principal Investigator
affiliation: University of Amsterdam
facility: 
country: Sierra Leone
citation: Leopold SJ, Ghose A, Plewes KA, Mazumder S, Pisani L, Kingston HWF, Paul S, Barua A, Sattar MA, Huson MAM, Walden AP, Henwood PC, Riviello ED, Schultz MJ, Day NPJ, Kumar Dutta A, White NJ, Dondorp AM. Point-of-care lung ultrasound for the detection of pulmonary manifestations of malaria and sepsis: An observational study. PLoS One. 2018 Dec 12;13(12):e0204832. doi: 10.1371/journal.pone.0204832. eCollection 2018.
PMID: 30540757
citation: Vercesi V, Pisani L, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MMA, Henwood PC, Walden A, Smit M, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. External confirmation and exploration of the Kigali modification for diagnosing moderate or severe ARDS. Intensive Care Med. 2018 Apr;44(4):523-524. doi: 10.1007/s00134-018-5048-5. Epub 2018 Jan 24. No abstract available. Erratum In: Intensive Care Med. 2018 Feb 20;:
PMID: 29368056
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof. Dr. Marcus J. Schultz
investigator title: Professor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Lung Injury
sharing ipd: Undecided