<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/NCT03296215</url>
  </required_header>
  <id_info>
    <org_study_id>Mahmoud Badwy2017</org_study_id>
    <nct_id>NCT03296215</nct_id>
  </id_info>
  <brief_title>Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals</brief_title>
  <official_title>Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Human health comprises many different states, ranging from perfect health to critical&#xD;
      illness, so medical facilities should be able to provide medical assistance tailored to the&#xD;
      patient's degree of disease.&#xD;
&#xD;
      The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with&#xD;
      potentially severe physiologic instability requiring technical and/or artificial life&#xD;
      support. The level of care in an ICU is greater than that available on the floor or&#xD;
      Intermediate Care Unit.&#xD;
&#xD;
      Because of the utilization of expensive resources, ICUs should, in general, be reserved for&#xD;
      those patients with reversible medical conditions who have a &quot;reasonable prospect of&#xD;
      substantial recovery&quot;.&#xD;
&#xD;
      About one third of hospital mortality occurs in critically ill patients in the intensive care&#xD;
      unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global&#xD;
      hospital costs.&#xD;
&#xD;
      It is well accepted that early appropriate referral of patients to an ICU can significantly&#xD;
      reduce early and possibly late mortality in the critically ill.At the same time improper&#xD;
      selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This&#xD;
      in turn adversely affects the dynamics the whole hospital.&#xD;
&#xD;
      The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and&#xD;
      intensive treatment for patients with acute or exacerbated respiratory failure caused by a&#xD;
      disease that is primarily respiratory.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">September 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>The purpose of study is determine prognosis of patients admitted in Respiratory Intensive Care Unit at Assiut University Hospitals.</measure>
    <time_frame>First 24hours of admission.</time_frame>
    <description>Assessment of Acute Physiology and Health Evaluation II (APHCHE II) score of each admitted case.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <description>Patterno of admitted cases in Respiratory Intensive Care Unit at Assiut University Hospitals and Outcome</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>To determine different patterns of admission and their Outcome</description>
    <arm_group_label>Observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Only patients admitted to repiratory ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with the following conditions are candidates for admission to the respiratory&#xD;
        Intensive Care Unit. The following conditions include, but are not limited to:&#xD;
&#xD;
          1. Acute respiratory failure requiring ventilatory support&#xD;
&#xD;
          2. Acute pulmonary embolism with haemodynamic instability&#xD;
&#xD;
          3. Massive haemoptysis&#xD;
&#xD;
          4. Upper airway obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who are generally not appropriate for respiratory ICU admission:&#xD;
&#xD;
          1. Irreversible brain damage&#xD;
&#xD;
          2. End stage cardiac, respiratory and liver disease with no options for transplant&#xD;
&#xD;
          3. Metastatic cancer unresponsive to chemotherapy and/or radiotherapy&#xD;
&#xD;
          4. Patients with non-traumatic coma leading to a persistent vegetative state (7,8,9,10)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Badwy, Resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yousef Ahmad, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahmoud Badwy, Resident</last_name>
    <phone>01016149089</phone>
    <email>mah55667755@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yousef Ahmad, Prof</last_name>
    <phone>01018184095</phone>
    <email>yousefahmad72@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Kahn JM, Goss CH, Heagerty PJ, Kramer AA, O'Brien CR, Rubenfeld GD. Hospital volume and the outcomes of mechanical ventilation. N Engl J Med. 2006 Jul 6;355(1):41-50. doi: 10.1056/NEJMsa053993.</citation>
    <PMID>16822995</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Badwy</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be available for primary Outcome</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months from study completion</ipd_time_frame>
    <ipd_access_criteria>Data access will be reviewed by internal independent review panel</ipd_access_criteria>
  </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/NCT03296215
org study id: Mahmoud Badwy2017
nct id: NCT03296215
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Human health comprises many different states, ranging from perfect health to critical
      illness, so medical facilities should be able to provide medical assistance tailored to the
      patient's degree of disease.

      The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with
      potentially severe physiologic instability requiring technical and/or artificial life
      support. The level of care in an ICU is greater than that available on the floor or
      Intermediate Care Unit.

      Because of the utilization of expensive resources, ICUs should, in general, be reserved for
      those patients with reversible medical conditions who have a "reasonable prospect of
      substantial recovery".

      About one third of hospital mortality occurs in critically ill patients in the intensive care
      unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global
      hospital costs.

      It is well accepted that early appropriate referral of patients to an ICU can significantly
      reduce early and possibly late mortality in the critically ill.At the same time improper
      selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This
      in turn adversely affects the dynamics the whole hospital.

      The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and
      intensive treatment for patients with acute or exacerbated respiratory failure caused by a
      disease that is primarily respiratory.
observational model: Cohort
time perspective: Prospective
measure: The purpose of study is determine prognosis of patients admitted in Respiratory Intensive Care Unit at Assiut University Hospitals.
time frame: First 24hours of admission.
description: Assessment of Acute Physiology and Health Evaluation II (APHCHE II) score of each admitted case.
arm group label: Observational
description: Patterno of admitted cases in Respiratory Intensive Care Unit at Assiut University Hospitals and Outcome
intervention type: Other
intervention name: Observational
description: To determine different patterns of admission and their Outcome
arm group label: Observational
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 86 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Badwy, Resident
role: Principal Investigator
affiliation: Assiut University
last name: Yousef Ahmad, Prof
role: Study Director
affiliation: Assiut University
last name: Mahmoud Badwy, Resident
phone: 01016149089
email: mah55667755@yahoo.com
last name: Yousef Ahmad, Prof
phone: 01018184095
email: yousefahmad72@yahoo.com
citation: Kahn JM, Goss CH, Heagerty PJ, Kramer AA, O'Brien CR, Rubenfeld GD. Hospital volume and the outcomes of mechanical ventilation. N Engl J Med. 2006 Jul 6;355(1):41-50. doi: 10.1056/NEJMsa053993.
PMID: 16822995
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Badwy
investigator title: Investigator
sharing ipd: Yes
ipd description: Individual participant data will be available for primary Outcome
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months from study completion
ipd access criteria: Data access will be reviewed by internal independent review panel