<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/NCT03267693</url>
  </required_header>
  <id_info>
    <org_study_id>Gastrointestinal tract and VAP</org_study_id>
    <nct_id>NCT03267693</nct_id>
  </id_info>
  <brief_title>Gastrointestinal Complications in Association With Oropharyngeal and Respiratory Infections in Mechanical Ventilation</brief_title>
  <official_title>Gastrointestinal Complications in Association With Oropharyngeal and Respiratory Infections in Mechanical Ventilation</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>
      Detection of gastrointestinal complications in mechanically ventilated critically ill&#xD;
      patients and its relation to oropharyngeal and respiratory infections in relation to&#xD;
      oropharyngeal and gastric PH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hospital acquired or nosocomial infections continue to be an important cause of morbidity and&#xD;
      mortality. The critically ill patient is at particular risk of developing intensive care unit&#xD;
      acquired infection, with the lungs being especially vulnerable. Nosocomial bacterial&#xD;
      pneumonia occurring after two days of mechanical ventilation is referred to as ventilator&#xD;
      associated pneumonia, and is the most common nosocomial infection seen in the intensive care&#xD;
      unit. Intubation of the trachea and mechanical ventilation is associated with a 7-fold to&#xD;
      21-fold increase in the incidence of pneumonia and up to 28% of patients receiving mechanical&#xD;
      ventilation will develop this complication. Its development is associated with an&#xD;
      attributable increase in morbidity and mortality. Ventilator associated pneumonia (VAP) is&#xD;
      defined as nosocomial pneumonia occurring in a patient after 48 hours of mechanical&#xD;
      ventilation via a tracheal or tracheostomy tube. It is commonly classified as either early&#xD;
      onset (occurring within 96 hours of start of mechanical ventilation) or late onset (.96 hours&#xD;
      after start of mechanical ventilation). It is a common condition, difficult to diagnose&#xD;
      accurately, and expensive to treat. Its development prolongs a patient's stay in the&#xD;
      intensive care unit (ICU), and is associated with significant morbidity and mortality. Most&#xD;
      cases seem to result from aspiration of pathogenic material that commonly colonises the&#xD;
      oropharyngeal airways of the critically ill. Simple measures to decrease the incidence of&#xD;
      aspiration or reduce the burden of colonisation of the oropharynx may aid in the prevention&#xD;
      of ventilator associated pneumonia. VAP is the infection that occurs 48 hours after&#xD;
      intubation, which was not incubated during the period of the patient's admission, and 72&#xD;
      hours after extubation.&#xD;
&#xD;
      The gastrointestinal tract is believed to play an important role in ventilator-associated&#xD;
      pneumonia (VAP), because during critical illness the stomach often is colonized with enteric&#xD;
      Gram-negative bacteria. These are the same bacteria that frequently are isolated from the&#xD;
      sputum of patients with VAP.&#xD;
&#xD;
      This is known as the &quot;gastropulmonary hypothesis&quot; and it postulates the following sequence.&#xD;
      First, the stomach is colonized by potentially pathogenic microorganisms, either from an&#xD;
      exogenous source (contaminated liquid injected into a nasogastric tube), or from an&#xD;
      endogenous source (Detection of gastrointestinal complications in mechanically ventilated&#xD;
      critically ill patients and its relation to oropharyngeal and respiratory infections in&#xD;
      relation to oropharyngeal and gastric PH duodenogastric reflux). This is followed by&#xD;
      retrograde colonization of the oropharynx . Finally, the lower respiratory tract is colonized&#xD;
      from sustained microaspiration of contaminated oropharyngeal (or gastric) secretions around&#xD;
      the endotracheal tube cuff.&#xD;
&#xD;
      The Role of Gastric pH on the Incidence of VAP&#xD;
&#xD;
      Under fasting conditions, gastric sterility is maintained by an acidic pH. Clinical evidence&#xD;
      suggests that a gastric pH of 3.5 prevents bacterial colonization, whereas a pH 4.0 is&#xD;
      associated with clinically important bacterial colonization and a higher incidence of&#xD;
      nosocomial pneumonia.&#xD;
&#xD;
      Critically-ill patients with either respiratory failure requiring mechanical ventilation or&#xD;
      coagulopathy are at increased risk for clinically important, stress-related GI bleeding .This&#xD;
      has been associated with a significantly higher mortality rate, compared to patients without&#xD;
      evidence of bleeding (48.5 vs 9.1%, p _ 0.001).&#xD;
&#xD;
      Giving that such patients show an increasing risk of important gastrointestinal (GI)&#xD;
      bleeding, stress-ulcer prophylaxis (SUP) has been recommended for the prevention of upper GI&#xD;
      hemorrhage. SUP strategy rely on drugs that block the secretion of gastric acid and increase&#xD;
      the gastric pH (histamine-2-receptor antagonists - H2RA, and proton pump inhibitor - PPI) and&#xD;
      those that does not alter gastric pH (sucralfate). The increase of gastric pH leads to&#xD;
      bacterial overgrowth and potential colonization of trachea determining a higher risk of VAP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">September 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measurement of gastric and oropharyngeal ph in mechanically ventilated patients</measure>
    <time_frame>30 minutes</time_frame>
    <description>correlation between gastric and oropharyngeal ph and presence of gastrointestinal and respiratory complications in mechanically ventilated patients</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ventilator Associated Pneumonia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Gastric and oropharyngeal PH</intervention_name>
    <description>measurement of gastric and oropharyngeal PH and their relation to respiratory and gastrointestinal complication in mechanically ventilated patients</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        male and female patients between 18 and 70 years in ICU units on mechanical ventilator&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all critically ill mechanically ventilated patients between 18 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients take drugs affect gastric and oropharyngeal PH such as antacids, proton pump&#xD;
             inhibitors, H2 receptor antagonists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Menna Allah Gamal Said, BSC</last_name>
    <phone>01028153777</phone>
    <email>menna1992@hotmail.com</email>
  </overall_contact>
  <reference>
    <citation>Hunter JD. Ventilator associated pneumonia. Postgrad Med J. 2006 Mar;82(965):172-8. doi: 10.1136/pgmj.2005.036905.</citation>
    <PMID>16517798</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Menna Allah Gamal</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>Respiratory Tract Infections</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</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/NCT03267693
org study id: Gastrointestinal tract and VAP
nct id: NCT03267693
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Detection of gastrointestinal complications in mechanically ventilated critically ill
      patients and its relation to oropharyngeal and respiratory infections in relation to
      oropharyngeal and gastric PH.
Hospital acquired or nosocomial infections continue to be an important cause of morbidity and
      mortality. The critically ill patient is at particular risk of developing intensive care unit
      acquired infection, with the lungs being especially vulnerable. Nosocomial bacterial
      pneumonia occurring after two days of mechanical ventilation is referred to as ventilator
      associated pneumonia, and is the most common nosocomial infection seen in the intensive care
      unit. Intubation of the trachea and mechanical ventilation is associated with a 7-fold to
      21-fold increase in the incidence of pneumonia and up to 28% of patients receiving mechanical
      ventilation will develop this complication. Its development is associated with an
      attributable increase in morbidity and mortality. Ventilator associated pneumonia (VAP) is
      defined as nosocomial pneumonia occurring in a patient after 48 hours of mechanical
      ventilation via a tracheal or tracheostomy tube. It is commonly classified as either early
      onset (occurring within 96 hours of start of mechanical ventilation) or late onset (.96 hours
      after start of mechanical ventilation). It is a common condition, difficult to diagnose
      accurately, and expensive to treat. Its development prolongs a patient's stay in the
      intensive care unit (ICU), and is associated with significant morbidity and mortality. Most
      cases seem to result from aspiration of pathogenic material that commonly colonises the
      oropharyngeal airways of the critically ill. Simple measures to decrease the incidence of
      aspiration or reduce the burden of colonisation of the oropharynx may aid in the prevention
      of ventilator associated pneumonia. VAP is the infection that occurs 48 hours after
      intubation, which was not incubated during the period of the patient's admission, and 72
      hours after extubation.

      The gastrointestinal tract is believed to play an important role in ventilator-associated
      pneumonia (VAP), because during critical illness the stomach often is colonized with enteric
      Gram-negative bacteria. These are the same bacteria that frequently are isolated from the
      sputum of patients with VAP.

      This is known as the "gastropulmonary hypothesis" and it postulates the following sequence.
      First, the stomach is colonized by potentially pathogenic microorganisms, either from an
      exogenous source (contaminated liquid injected into a nasogastric tube), or from an
      endogenous source (Detection of gastrointestinal complications in mechanically ventilated
      critically ill patients and its relation to oropharyngeal and respiratory infections in
      relation to oropharyngeal and gastric PH duodenogastric reflux). This is followed by
      retrograde colonization of the oropharynx . Finally, the lower respiratory tract is colonized
      from sustained microaspiration of contaminated oropharyngeal (or gastric) secretions around
      the endotracheal tube cuff.

      The Role of Gastric pH on the Incidence of VAP

      Under fasting conditions, gastric sterility is maintained by an acidic pH. Clinical evidence
      suggests that a gastric pH of 3.5 prevents bacterial colonization, whereas a pH 4.0 is
      associated with clinically important bacterial colonization and a higher incidence of
      nosocomial pneumonia.

      Critically-ill patients with either respiratory failure requiring mechanical ventilation or
      coagulopathy are at increased risk for clinically important, stress-related GI bleeding .This
      has been associated with a significantly higher mortality rate, compared to patients without
      evidence of bleeding (48.5 vs 9.1%, p _ 0.001).

      Giving that such patients show an increasing risk of important gastrointestinal (GI)
      bleeding, stress-ulcer prophylaxis (SUP) has been recommended for the prevention of upper GI
      hemorrhage. SUP strategy rely on drugs that block the secretion of gastric acid and increase
      the gastric pH (histamine-2-receptor antagonists - H2RA, and proton pump inhibitor - PPI) and
      those that does not alter gastric pH (sucralfate). The increase of gastric pH leads to
      bacterial overgrowth and potential colonization of trachea determining a higher risk of VAP.
observational model: Other
time perspective: Cross-Sectional
measure: measurement of gastric and oropharyngeal ph in mechanically ventilated patients
time frame: 30 minutes
description: correlation between gastric and oropharyngeal ph and presence of gastrointestinal and respiratory complications in mechanically ventilated patients
intervention type: Diagnostic Test
intervention name: Gastric and oropharyngeal PH
description: measurement of gastric and oropharyngeal PH and their relation to respiratory and gastrointestinal complication in mechanically ventilated patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Menna Allah Gamal Said, BSC
phone: 01028153777
email: menna1992@hotmail.com
citation: Hunter JD. Ventilator associated pneumonia. Postgrad Med J. 2006 Mar;82(965):172-8. doi: 10.1136/pgmj.2005.036905.
PMID: 16517798
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Menna Allah Gamal
investigator title: Principal Investigator
mesh term: Respiratory Tract Infections
mesh term: Pneumonia, Ventilator-Associated