<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/NCT03234582</url>
  </required_header>
  <id_info>
    <org_study_id>NK/3021/pH/110</org_study_id>
    <nct_id>NCT03234582</nct_id>
  </id_info>
  <brief_title>Comparison of RVOT Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing TOF Repair</brief_title>
  <official_title>Comparison of Right Ventricular Outflow Tract Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing Tetralogy of Fallot Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</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>
      The primary objective of the study will be to compare intraoperative post TOF repair RVOT&#xD;
      gradient under two different anaesthetic depths. Secondary objectives will be to follow up&#xD;
      change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes&#xD;
      used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from&#xD;
      ICU and at 1 month follow- up&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After completion of the TOF repair and rewarming to normothermia, all the patients will be&#xD;
      assessed by TEE for adequacy of repair and separated from the cardiopulmonary bypass using&#xD;
      vasopressors and inotropes. The choice of vasoactive and inotropic agents will be as per the&#xD;
      requirement to maintain stable hemodynamics of the patients. Post bypass sevoflurane 1% end&#xD;
      tidal concentration (0.5 MAC) will be used in all the patients. RV pressure and gradients&#xD;
      across RVOT will be measured directly by placing a 23 gauge needle into the RV and pulmonary&#xD;
      artery, and also by TEE using Bernoulli's equation by placing continuous Doppler across&#xD;
      tricuspid regurgitation jet and RVOT, as is being routinely done for patients undergoing TOF&#xD;
      repair. In addition, velocity time integral (VTI) across left ventricular outflow tract&#xD;
      (LVOT) will also be recorded along with other hemodynamic parameters such as HR, SBP, DBP,&#xD;
      MAP and SpO2. Subsequently, these measurements will be repeated again after increasing the&#xD;
      sevoflurane to 2% end tidal concentration (1 MAC) and allowing the patients to stabilise on&#xD;
      this new concentration for 5 minutes while maintaining systemic pressure within a range of 5%&#xD;
      of the previous value. Normocarbia (EtCO2 30-35 mmHg) will be maintained during these&#xD;
      measurements by adequate minute ventilation.&#xD;
&#xD;
      Following the surgery, all the patients will be shifted to cardio-surgical ICU and will be&#xD;
      extubated once they meet the extubation criteria. Post-operative RVOT pressure gradient and&#xD;
      RV functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at&#xD;
      discharge from ICU and after 1 month of surgery on first follow-up. RV functions on&#xD;
      echocardiography will be assessed using TAPSE (Tricuspid annular plane systolic excursion)&#xD;
      and fractional RV area change during systole. The duration of post-operative mechanical&#xD;
      ventilation, vasoactive inotropic score (VIS), PaO2/FiO2 ratio till discharge from ICU and&#xD;
      any morbidity or adverse outcome during hospital stay will be noted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair</measure>
    <time_frame>15 minutes</time_frame>
    <description>The primary objective of the study will be to compare intra-operative post TOF repair RVOT gradient under two different anaesthetic depths</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of change in right ventricular outflow tract gradient post-operatively in patients undergoing tetralogy of Fallot repair</measure>
    <time_frame>1 month</time_frame>
    <description>To follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes use post-operatively by vasoactive-inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow-up</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Tetralogy of Fallot</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All the children between 6 months to 16 years of age undergoing TOF repair will be included&#xD;
        in the study.TOF patients with pulmonary atresia, atrioventricular canal defects and where&#xD;
        consent is refused will be excluded from the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the children between 6 months to 16 years of age undergoing TOF repair will be&#xD;
             included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  TOF patients with pulmonary atresia, atrioventricular canal defects and where consent&#xD;
             is refused will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Dr. Dheemta Toshkhani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nandita Kakkar</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 9, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr. Dheemta Toshkhani</investigator_full_name>
    <investigator_title>Junior Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetralogy of Fallot</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 1, 2018</submitted>
    <returned>January 17, 2019</returned>
    <submitted>February 13, 2019</submitted>
    <returned>June 7, 2019</returned>
  </pending_results>
  <!-- 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/NCT03234582
org study id: NK/3021/pH/110
nct id: NCT03234582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study will be to compare intraoperative post TOF repair RVOT
      gradient under two different anaesthetic depths. Secondary objectives will be to follow up
      change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes
      used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from
      ICU and at 1 month follow- up
After completion of the TOF repair and rewarming to normothermia, all the patients will be
      assessed by TEE for adequacy of repair and separated from the cardiopulmonary bypass using
      vasopressors and inotropes. The choice of vasoactive and inotropic agents will be as per the
      requirement to maintain stable hemodynamics of the patients. Post bypass sevoflurane 1% end
      tidal concentration (0.5 MAC) will be used in all the patients. RV pressure and gradients
      across RVOT will be measured directly by placing a 23 gauge needle into the RV and pulmonary
      artery, and also by TEE using Bernoulli's equation by placing continuous Doppler across
      tricuspid regurgitation jet and RVOT, as is being routinely done for patients undergoing TOF
      repair. In addition, velocity time integral (VTI) across left ventricular outflow tract
      (LVOT) will also be recorded along with other hemodynamic parameters such as HR, SBP, DBP,
      MAP and SpO2. Subsequently, these measurements will be repeated again after increasing the
      sevoflurane to 2% end tidal concentration (1 MAC) and allowing the patients to stabilise on
      this new concentration for 5 minutes while maintaining systemic pressure within a range of 5%
      of the previous value. Normocarbia (EtCO2 30-35 mmHg) will be maintained during these
      measurements by adequate minute ventilation.

      Following the surgery, all the patients will be shifted to cardio-surgical ICU and will be
      extubated once they meet the extubation criteria. Post-operative RVOT pressure gradient and
      RV functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at
      discharge from ICU and after 1 month of surgery on first follow-up. RV functions on
      echocardiography will be assessed using TAPSE (Tricuspid annular plane systolic excursion)
      and fractional RV area change during systole. The duration of post-operative mechanical
      ventilation, vasoactive inotropic score (VIS), PaO2/FiO2 ratio till discharge from ICU and
      any morbidity or adverse outcome during hospital stay will be noted.
observational model: Other
time perspective: Prospective
measure: Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair
time frame: 15 minutes
description: The primary objective of the study will be to compare intra-operative post TOF repair RVOT gradient under two different anaesthetic depths
measure: Comparison of change in right ventricular outflow tract gradient post-operatively in patients undergoing tetralogy of Fallot repair
time frame: 1 month
description: To follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes use post-operatively by vasoactive-inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 16 Years
last name: Dr. Dheemta Toshkhani, MD
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr. Dheemta Toshkhani
investigator title: Junior Resident
mesh term: Tetralogy of Fallot
submitted: August 1, 2018
returned: January 17, 2019
submitted: February 13, 2019
returned: June 7, 2019