<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/NCT04410757</url>
  </required_header>
  <id_info>
    <org_study_id>5180035</org_study_id>
    <nct_id>NCT04410757</nct_id>
  </id_info>
  <brief_title>Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit</brief_title>
  <official_title>Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit- A Collaborative Observational Study Between UCLA and Loma Linda University Medical Centers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational research study is to examine how point-of care ultrasound&#xD;
      affects the workup and management of perioperative complications for specific clinical&#xD;
      scenarios of low blood pressure (hypotension), low blood oxygen (hypoxemia), in the post-&#xD;
      anesthesia care unit (PACU).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">May 27, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>post anesthesia care (PACU) unit length of stay (minutes)</measure>
    <time_frame>during year of the study enrollment</time_frame>
    <description>The primary outcome marker for the study was post anesthesia care (PACU) unit length of stay (minutes), with a hypothesis that patients receiving a POCUS examination for the cardiovascular or pulmonary event would have a shorter PACU LOS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of diagnosis before and after assessment</measure>
    <time_frame>during of the study enrollment</time_frame>
    <description>Additional markers include a POCUS report completed by the performing attending anesthesiologist that included POCUS findings and the number of potential diagnoses to explain the acute event (hypoxia and/or hypotension) before and after the POCUS exam was performed..</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>Hypotension</condition>
  <condition>Hypoxemia</condition>
  <condition>Altered Mental Status</condition>
  <condition>Urine Output Low</condition>
  <condition>Chest Pain</condition>
  <arm_group>
    <arm_group_label>Point of Care Ultrasound (POCUS) group</arm_group_label>
    <description>When the provider in charge of covering the post-anesthesia care unit, they would apply POCUS examinations in their PACU assessment as per the study protocol of hypotensive and hypoxic events.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Point of Care Ultrasound (POCUS) group</arm_group_label>
    <description>When the provider in charge of covering the post-anesthesia care unit, they would apply routine bedside examination techniques in their PACU assessment as per the study protocol of hypotensive and hypoxic events.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatient or outpatient subjects from the age 18 and above with no maximum age limit&#xD;
        admitted in the post-anesthesia care unit (PACU) that experienced a hypoxic or hypotensive&#xD;
        event and were examined by a physician.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in the post-anesthesia care unit with the following events&#xD;
&#xD;
          -  Mean arterial blood pressure &lt;60 mmHg or &lt;20% of pre-operative baseline mean arterial&#xD;
             blood pressure,) hypoxemia (pulse oximetry saturation &lt;95% or Pao2 &lt;80), altered&#xD;
             mental status, decreased urine output, chest pain/EKG changes, or to confirm&#xD;
             endotracheal Lube placement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not able to have a point of care ultrasound examination in the post&#xD;
             anesthesia recovery area.&#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>Davinder Ramsingh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Department of Anesthesiology</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ramsingh D, Rinehart J, Kain Z, Strom S, Canales C, Alexander B, Capatina A, Ma M, Le KV, Cannesson M. Impact assessment of perioperative point-of-care ultrasound training on anesthesiology residents. Anesthesiology. 2015 Sep;123(3):670-82. doi: 10.1097/ALN.0000000000000776.</citation>
    <PMID>26181338</PMID>
  </reference>
  <reference>
    <citation>Canty DJ, Royse CF, Kilpatrick D, Bowman L, Royse AG. The impact of focused transthoracic echocardiography in the pre-operative clinic. Anaesthesia. 2012 Jun;67(6):618-25. doi: 10.1111/j.1365-2044.2012.07074.x. Epub 2012 Feb 21.</citation>
    <PMID>22352785</PMID>
  </reference>
  <reference>
    <citation>Ford JW, Heiberg J, Brennan AP, Royse CF, Canty DJ, El-Ansary D, Royse AG. A Pilot Assessment of 3 Point-of-Care Strategies for Diagnosis of Perioperative Lung Pathology. Anesth Analg. 2017 Mar;124(3):734-742. doi: 10.1213/ANE.0000000000001726.</citation>
    <PMID>27828799</PMID>
  </reference>
  <reference>
    <citation>Haskins SC, Desai NA, Fields KG, Nejim JA, Cheng S, Coleman SH, Nawabi DH, Kelly BT. Diagnosis of Intraabdominal Fluid Extravasation After Hip Arthroscopy With Point-of-Care Ultrasonography Can Identify Patients at an Increased Risk for Postoperative Pain. Anesth Analg. 2017 Mar;124(3):791-799. doi: 10.1213/ANE.0000000000001435.</citation>
    <PMID>27551733</PMID>
  </reference>
  <reference>
    <citation>Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.</citation>
    <PMID>25951832</PMID>
  </reference>
  <reference>
    <citation>Shokoohi H, Boniface KS, Pourmand A, Liu YT, Davison DL, Hawkins KD, Buhumaid RE, Salimian M, Yadav K. Bedside Ultrasound Reduces Diagnostic Uncertainty and Guides Resuscitation in Patients With Undifferentiated Hypotension. Crit Care Med. 2015 Dec;43(12):2562-9. doi: 10.1097/CCM.0000000000001285.</citation>
    <PMID>26575653</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Davinder Ramsingh, MD</investigator_full_name>
    <investigator_title>Director of Clinical Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04410757
org study id: 5180035
nct id: NCT04410757
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational research study is to examine how point-of care ultrasound
      affects the workup and management of perioperative complications for specific clinical
      scenarios of low blood pressure (hypotension), low blood oxygen (hypoxemia), in the post-
      anesthesia care unit (PACU).
observational model: Case-Control
time perspective: Other
measure: post anesthesia care (PACU) unit length of stay (minutes)
time frame: during year of the study enrollment
description: The primary outcome marker for the study was post anesthesia care (PACU) unit length of stay (minutes), with a hypothesis that patients receiving a POCUS examination for the cardiovascular or pulmonary event would have a shorter PACU LOS.
measure: number of diagnosis before and after assessment
time frame: during of the study enrollment
description: Additional markers include a POCUS report completed by the performing attending anesthesiologist that included POCUS findings and the number of potential diagnoses to explain the acute event (hypoxia and/or hypotension) before and after the POCUS exam was performed..
arm group label: Point of Care Ultrasound (POCUS) group
description: When the provider in charge of covering the post-anesthesia care unit, they would apply POCUS examinations in their PACU assessment as per the study protocol of hypotensive and hypoxic events.
arm group label: No Point of Care Ultrasound (POCUS) group
description: When the provider in charge of covering the post-anesthesia care unit, they would apply routine bedside examination techniques in their PACU assessment as per the study protocol of hypotensive and hypoxic events.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Davinder Ramsingh, MD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
citation: Ramsingh D, Rinehart J, Kain Z, Strom S, Canales C, Alexander B, Capatina A, Ma M, Le KV, Cannesson M. Impact assessment of perioperative point-of-care ultrasound training on anesthesiology residents. Anesthesiology. 2015 Sep;123(3):670-82. doi: 10.1097/ALN.0000000000000776.
PMID: 26181338
citation: Canty DJ, Royse CF, Kilpatrick D, Bowman L, Royse AG. The impact of focused transthoracic echocardiography in the pre-operative clinic. Anaesthesia. 2012 Jun;67(6):618-25. doi: 10.1111/j.1365-2044.2012.07074.x. Epub 2012 Feb 21.
PMID: 22352785
citation: Ford JW, Heiberg J, Brennan AP, Royse CF, Canty DJ, El-Ansary D, Royse AG. A Pilot Assessment of 3 Point-of-Care Strategies for Diagnosis of Perioperative Lung Pathology. Anesth Analg. 2017 Mar;124(3):734-742. doi: 10.1213/ANE.0000000000001726.
PMID: 27828799
citation: Haskins SC, Desai NA, Fields KG, Nejim JA, Cheng S, Coleman SH, Nawabi DH, Kelly BT. Diagnosis of Intraabdominal Fluid Extravasation After Hip Arthroscopy With Point-of-Care Ultrasonography Can Identify Patients at an Increased Risk for Postoperative Pain. Anesth Analg. 2017 Mar;124(3):791-799. doi: 10.1213/ANE.0000000000001435.
PMID: 27551733
citation: Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.
PMID: 25951832
citation: Shokoohi H, Boniface KS, Pourmand A, Liu YT, Davison DL, Hawkins KD, Buhumaid RE, Salimian M, Yadav K. Bedside Ultrasound Reduces Diagnostic Uncertainty and Guides Resuscitation in Patients With Undifferentiated Hypotension. Crit Care Med. 2015 Dec;43(12):2562-9. doi: 10.1097/CCM.0000000000001285.
PMID: 26575653
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Davinder Ramsingh, MD
investigator title: Director of Clinical Research
mesh term: Hypotension
mesh term: Chest Pain
mesh term: Hypoxia