<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/NCT03031860</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0000871237</org_study_id>
    <nct_id>NCT03031860</nct_id>
  </id_info>
  <brief_title>Semi-quantitative Cough Strength Score (SCSS)</brief_title>
  <official_title>Impact of Semi-quantitative Cough Strength Score as a Strong Predictor for Extubation Outcome in Head Trauma Patients: a Prospective Descriptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Cough strength score will give true prediction of Extubation outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation. If&#xD;
      they had completed an Spontaneous Breathing Trial (SBT) before extubation. To measure&#xD;
      Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30°&#xD;
      to 45°, measure SCSS, first. The investigator enhance the patient to cough with as much&#xD;
      effort as, when the investigator disconnect the ventilator. The cough strength was scored&#xD;
      from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the&#xD;
      endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly&#xD;
      audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Extubation outcome (success or failure), is the patient reintubate again or not and it's correlation with the level of Cough Strength Score</measure>
    <time_frame>within 6 hours postextubation</time_frame>
    <description>The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.</description>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Mechanical Ventilation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Semiquantitative Cough Strength Score</intervention_name>
    <description>Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score</description>
    <other_name>(SCSS)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The sample of this study include 80 head trauma patients from both sex of critically ill&#xD;
        mechanically ventilated patient admitted to trauma Intensive Care Unit (ICU).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study included 80 adult male and female patients' their ages between 18-65 years&#xD;
             admitted to trauma ICU with head trauma, on mechanical ventilation more than 24 hours&#xD;
             and was ready to be weaned off from mechanical ventilation after successful&#xD;
             spontaneous breathing trial and Glasgow Coma Scale (GCS) score &gt; 8 before extubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients who had undergone tracheostomy before extubation, GCS ≤ 8, chest trauma (ribs&#xD;
        fracture and lung contusion) and patients with chronic chest disease (Chronic obstructive&#xD;
        pulmonary disease, tuberculosis and cancer lung) were excluded from the study.&#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>Eman M Aziz</last_name>
    <role>Principal Investigator</role>
    <affiliation>assiut university faculty of nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university faculty of medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850.</citation>
    <PMID>22663965</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Abdelrady S Ibrahim, MD</investigator_full_name>
    <investigator_title>Assistant professor of anesthesia and ICU</investigator_title>
  </responsible_party>
  <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/NCT03031860
org study id: IRB0000871237
nct id: NCT03031860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cough strength score will give true prediction of Extubation outcome
Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation. If
      they had completed an Spontaneous Breathing Trial (SBT) before extubation. To measure
      Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30°
      to 45°, measure SCSS, first. The investigator enhance the patient to cough with as much
      effort as, when the investigator disconnect the ventilator. The cough strength was scored
      from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the
      endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly
      audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
observational model: Other
time perspective: Prospective
measure: Extubation outcome (success or failure), is the patient reintubate again or not and it's correlation with the level of Cough Strength Score
time frame: within 6 hours postextubation
description: The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
intervention type: Other
intervention name: Semiquantitative Cough Strength Score
description: Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score
other name: (SCSS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Eman M Aziz
role: Principal Investigator
affiliation: assiut university faculty of nursing
facility: 
country: Egypt
citation: White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850.
PMID: 22663965
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Abdelrady S Ibrahim, MD
investigator title: Assistant professor of anesthesia and ICU
sharing ipd: Undecided