xml: <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/NCT06039995</url>
    </required_header>
    <id_info>
      <org_study_id>VAP RCT 23</org_study_id>
      <nct_id>NCT06039995</nct_id>
    </id_info>
    <brief_title>The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.</brief_title>
    <official_title>The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Health Sciences Lahore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Health Sciences Lahore</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 study in question is a Randomized Controlled Trial (RCT) conducted at Services Hospital,&#xD;
        Lahore, over a three-month duration. It aims to assess the effects of including adjuvant oral&#xD;
        care as part of traditional oral care in reducing the incidence and mortality rates of&#xD;
        Ventilator-Associated Pneumonia (VAP) while also shortening the length of ICU stays among&#xD;
        patients on mechanical ventilation. This research holds the potential to bring significant&#xD;
        improvements to patient care and reduce the burden of VAP in critical care settings.&#xD;
  &#xD;
        Study Objectives:&#xD;
  &#xD;
        Population Focus: The study focuses on patients admitted to the intensive care unit (ICU) who&#xD;
        are receiving mechanical ventilation.&#xD;
  &#xD;
        Research Question: The central question this study seeks to answer is: Does the inclusion of&#xD;
        adjuvant oral care alongside traditional oral care reduce the incidence and mortality rates&#xD;
        of VAP and shorten the length of ICU stay among patients on mechanical ventilation?&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        Sample Selection: The study aims to include a minimum of 100 subjects who meet the inclusion&#xD;
        criteria. These subjects will be selected through convenient sampling.&#xD;
  &#xD;
        Randomization: To ensure unbiased allocation, subjects will be randomly assigned to either&#xD;
        the control group or the intervention group using computer software.&#xD;
  &#xD;
        Interventions: The intervention group will receive a combination of interventions, including&#xD;
        Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the&#xD;
        interior and exterior surfaces of the oral cavity. In contrast, the control group will&#xD;
        receive traditional oral care involving the use of 0.2% Chlorhexidine mouthwash only.&#xD;
  &#xD;
        Outcome Measures: The study will evaluate the incidence of VAP by employing the Modified&#xD;
        Clinical Pulmonary Infection Score (MCPIS). Additionally, demographic characteristics such as&#xD;
        age, gender, smoking history, duration of ICU stay, and mortality rates will be compared&#xD;
        between the two groups.&#xD;
  &#xD;
        Statistical Analysis: Data analysis will be conducted using SPSS version 22, employing&#xD;
        appropriate statistical methods and tests to draw meaningful conclusions.&#xD;
  &#xD;
        Expected Impact:&#xD;
  &#xD;
        The findings of this study hold significant potential to reduce VAP rates and improve patient&#xD;
        outcomes in ICU settings. The incorporation of toothbrushing and moisturizing gel alongside&#xD;
        Chlorhexidine mouthwash may enhance the cost-effectiveness of treatment and benefit&#xD;
        healthcare professionals. This approach could potentially lead to shorter ICU stays,&#xD;
        ultimately reducing the burden of VAP in critical care settings.&#xD;
  &#xD;
        Furthermore, the implementation of comprehensive oral care practices beyond traditional&#xD;
        methods has the potential to improve patient care, decrease mortality rates, and alleviate&#xD;
        the strain on healthcare resources by potentially reducing the duration of ICU stays. In sum,&#xD;
        this research contributes to the broader goal of reducing the incidence of VAP and enhancing&#xD;
        overall patient care in intensive care units.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 10, 2023</start_date>
    <completion_date type="Anticipated">January 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Ventilator-Associated Pneumonia (VAP)</measure>
      <time_frame>The time frame for assessing the incidence of VAP in this study spans the entire three-month duration of the research conducted at Services Hospital, Lahore.</time_frame>
      <description>This outcome measures the occurrence of Ventilator-Associated Pneumonia (VAP) among patients who are on mechanical ventilation in the intensive care unit (ICU). It serves as a critical indicator of the effectiveness of the intervention, which includes adjuvant oral care, in reducing the risk of VAP.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of ICU Stay</measure>
      <time_frame>These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.</time_frame>
      <description>The duration of ICU stay will be recorded for each patient. This data will help evaluate whether the intervention affects the length of ICU stay and potentially reduces healthcare resource utilization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality Rates</measure>
      <time_frame>These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.</time_frame>
      <description>Mortality rates in both the control and intervention groups will be compared to assess if the adjuvant oral care intervention has an impact on patient survival during their ICU stay.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Pneumonia, Ventilator-Associated</condition>
    <arm_group>
      <arm_group_label>(Adjuvant Oral Care) Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>(Traditional Oral Care) Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group represents the control arm of the study. Patients in this arm receive traditional oral care, which involves the use of 0.2% Chlorhexidine mouthwash only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Comprehensive Oral Care</intervention_name>
      <description>The intervention mentioned in this study involves a combination of oral care strategies for patients in the intervention group. These strategies include:&#xD;
  Chlorhexidine Mouthwash: Patients in the intervention group will receive Chlorhexidine mouthwash. Chlorhexidine is known for its effectiveness in maintaining oral hygiene.&#xD;
  Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.&#xD;
  Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.&#xD;
  These interventions aim to enhance oral care beyond traditional methods, potentially reducing the risk of Ventilator-Associated Pneumonia (VAP) and improving overall patient outcomes in the intensive care unit (ICU).</description>
      <arm_group_label>(Adjuvant Oral Care) Intervention Group</arm_group_label>
      <other_name>Adjuvant oral care as a component of traditional oral care</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Traditional Oral Care</intervention_name>
      <description>In the control arm, patients receive the intervention known as &quot;Traditional Oral Care.&quot; This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene.</description>
      <arm_group_label>(Traditional Oral Care) Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Mechanical Tooth Brushing using 0.2% Chlorhexidine</intervention_name>
      <description>Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.</description>
      <arm_group_label>(Adjuvant Oral Care) Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Moisturizing Gel</intervention_name>
      <description>Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.</description>
      <arm_group_label>(Adjuvant Oral Care) Intervention Group</arm_group_label>
      <other_name>Veramin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Oral care using Cotton swab dipped in 0.2% Chlorhexidine</intervention_name>
      <description>This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene</description>
      <arm_group_label>(Traditional Oral Care) Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ICU patients on intensive mechanical ventilation aged 18-65 years of either sex with&#xD;
               oral ETT in situ.&#xD;
  &#xD;
            -  MCPIS score between 0 to 5 on first day of admission at ICU&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  More than 48 hours of mechanical ventilation before ICU admission.&#xD;
  &#xD;
            -  Previous history of respiratory illness.&#xD;
  &#xD;
            -  Immunocompromised.&#xD;
  &#xD;
            -  Ongoing sepsis.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Presence of dentures.&#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>Akash Samuel, MS Nursing</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Health Sciences Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Akash Samuel, MS Nursing</last_name>
      <phone>03421532346</phone>
      <email>akashsamuel20@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Health Sciences Lahore</investigator_affiliation>
      <investigator_full_name>Akash Samuel</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</mesh_term>
      <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chlorhexidine</mesh_term>
      <mesh_term>Chlorhexidine gluconate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039995
  org study id: VAP RCT 23
  nct id: NCT06039995
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study in question is a Randomized Controlled Trial (RCT) conducted at Services Hospital,
        Lahore, over a three-month duration. It aims to assess the effects of including adjuvant oral
        care as part of traditional oral care in reducing the incidence and mortality rates of
        Ventilator-Associated Pneumonia (VAP) while also shortening the length of ICU stays among
        patients on mechanical ventilation. This research holds the potential to bring significant
        improvements to patient care and reduce the burden of VAP in critical care settings.
  
        Study Objectives:
  
        Population Focus: The study focuses on patients admitted to the intensive care unit (ICU) who
        are receiving mechanical ventilation.
  
        Research Question: The central question this study seeks to answer is: Does the inclusion of
        adjuvant oral care alongside traditional oral care reduce the incidence and mortality rates
        of VAP and shorten the length of ICU stay among patients on mechanical ventilation?
  
        Methodology:
  
        Sample Selection: The study aims to include a minimum of 100 subjects who meet the inclusion
        criteria. These subjects will be selected through convenient sampling.
  
        Randomization: To ensure unbiased allocation, subjects will be randomly assigned to either
        the control group or the intervention group using computer software.
  
        Interventions: The intervention group will receive a combination of interventions, including
        Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the
        interior and exterior surfaces of the oral cavity. In contrast, the control group will
        receive traditional oral care involving the use of 0.2% Chlorhexidine mouthwash only.
  
        Outcome Measures: The study will evaluate the incidence of VAP by employing the Modified
        Clinical Pulmonary Infection Score (MCPIS). Additionally, demographic characteristics such as
        age, gender, smoking history, duration of ICU stay, and mortality rates will be compared
        between the two groups.
  
        Statistical Analysis: Data analysis will be conducted using SPSS version 22, employing
        appropriate statistical methods and tests to draw meaningful conclusions.
  
        Expected Impact:
  
        The findings of this study hold significant potential to reduce VAP rates and improve patient
        outcomes in ICU settings. The incorporation of toothbrushing and moisturizing gel alongside
        Chlorhexidine mouthwash may enhance the cost-effectiveness of treatment and benefit
        healthcare professionals. This approach could potentially lead to shorter ICU stays,
        ultimately reducing the burden of VAP in critical care settings.
  
        Furthermore, the implementation of comprehensive oral care practices beyond traditional
        methods has the potential to improve patient care, decrease mortality rates, and alleviate
        the strain on healthcare resources by potentially reducing the duration of ICU stays. In sum,
        this research contributes to the broader goal of reducing the incidence of VAP and enhancing
        overall patient care in intensive care units.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Incidence of Ventilator-Associated Pneumonia (VAP)
  time frame: The time frame for assessing the incidence of VAP in this study spans the entire three-month duration of the research conducted at Services Hospital, Lahore.
  description: This outcome measures the occurrence of Ventilator-Associated Pneumonia (VAP) among patients who are on mechanical ventilation in the intensive care unit (ICU). It serves as a critical indicator of the effectiveness of the intervention, which includes adjuvant oral care, in reducing the risk of VAP.
  measure: Duration of ICU Stay
  time frame: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
  description: The duration of ICU stay will be recorded for each patient. This data will help evaluate whether the intervention affects the length of ICU stay and potentially reduces healthcare resource utilization
  measure: Mortality Rates
  time frame: These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.
  description: Mortality rates in both the control and intervention groups will be compared to assess if the adjuvant oral care intervention has an impact on patient survival during their ICU stay.
  arm group label: (Adjuvant Oral Care) Intervention Group
  arm group type: Experimental
  description: This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.
  arm group label: (Traditional Oral Care) Control Group
  arm group type: Active Comparator
  description: This group represents the control arm of the study. Patients in this arm receive traditional oral care, which involves the use of 0.2% Chlorhexidine mouthwash only.
  intervention type: Procedure
  intervention name: Comprehensive Oral Care
  description: The intervention mentioned in this study involves a combination of oral care strategies for patients in the intervention group. These strategies include:
  Chlorhexidine Mouthwash: Patients in the intervention group will receive Chlorhexidine mouthwash. Chlorhexidine is known for its effectiveness in maintaining oral hygiene.
  Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.
  Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.
  These interventions aim to enhance oral care beyond traditional methods, potentially reducing the risk of Ventilator-Associated Pneumonia (VAP) and improving overall patient outcomes in the intensive care unit (ICU).
  arm group label: (Adjuvant Oral Care) Intervention Group
  other name: Adjuvant oral care as a component of traditional oral care
  intervention type: Procedure
  intervention name: Traditional Oral Care
  description: In the control arm, patients receive the intervention known as "Traditional Oral Care." This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene.
  arm group label: (Traditional Oral Care) Control Group
  intervention type: Device
  intervention name: Mechanical Tooth Brushing using 0.2% Chlorhexidine
  description: Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.
  arm group label: (Adjuvant Oral Care) Intervention Group
  intervention type: Device
  intervention name: Moisturizing Gel
  description: Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.
  arm group label: (Adjuvant Oral Care) Intervention Group
  other name: Veramin
  intervention type: Device
  intervention name: Oral care using Cotton swab dipped in 0.2% Chlorhexidine
  description: This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene
  arm group label: (Traditional Oral Care) Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Akash Samuel, MS Nursing
  role: Principal Investigator
  affiliation: University of Health Sciences Lahore
  last name: Akash Samuel, MS Nursing
  phone: 03421532346
  email: akashsamuel20@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: University of Health Sciences Lahore
  investigator full name: Akash Samuel
  investigator title: Principal Investigator
  mesh term: Pneumonia
  mesh term: Pneumonia, Ventilator-Associated
  mesh term: Chlorhexidine
  mesh term: Chlorhexidine gluconate
  sharing ipd: No