Clinical Trial: Ventilator Associated Pneumonia in Taper Guard Versus Normal Tube in ICU Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of the Incidence of Ventilator Associated Pneumonia in Patients Intubated With the Taper Guard Endotracheal Tube Versus a Normal Endotracheal Tube

Brief Summary: Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients as they may cause the death of the patient or prolong the intensive care stay or complicate the illness in other ways. The risk of infection is dependent on the interplay between bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria load reduction and this includes the use of subglottic suctioning in an attempt to reduce the amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow subglottic suctioning was significantly effective in reducing the incidence of ventilator associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a new tapering design may be even more useful to provide the solution for bacterial load reduction. Conventional tubes which may furrow on themselves to allow the creation of microchannels may aid microaspiration. The taper guard which has facilities for subglottic suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to the problem of ventilator associated pneumonia. This study is to determine the extent of protection this tube has against ventilator associated pneumonia compared with conventional endotracheal tubes

Detailed Summary:

Methodology This will be a prospective randomized trial with 2 treatment groups with 100 patients in each arm. The control group ( Group C) will be intubated with our conventional endotracheal tubes and the test group ( Group T) will be intubated with the special Taper guard tubes with subglottic suctioning and snug fit facilities.

All adult patients ( > 18 years of age) admitted into the Intensive Care Unit who are likely to receive more than 72 hours of ventilation will be admitted into the trial. The trial has been cleared by the Hospital Ethics and informed consent will be obtained from the patient's next of kin.

All patients will have their demographic data collected, the primary reason for ICU admission, the APACHE 2 scores, presence of infection at admission, antibiotic use and whether they have risk factors for VAP ( previous surgery, trauma, antibiotics usage, reflux disease and use of stress ulcer prophylaxis, decreased immune status ) The following guidelines modified from the American Thoracic Society 2005 will be used as the basis for diagnosing Ventilator Associated Pneumonia.

Guideline for Diagnosis of Ventilator Associated Pneumonia (VAP)2

1. Patient ventilated for more than 48 hours.
2. Suspicion of ventilation associated pneumonia
3. Presence of a new or progressive infiltrate on chest radiograph.

4. At least 2 of the following:

   1. Fever, defined as an oral temperature greater than 38 degree C, a tympanic temperature greater than 38.5 degree C or a rectal /c
      Sponsor: University of Malaya
      

      Current Primary Outcome: incidence of ventilator associated pneumonia(VAP) [ Time Frame: 72 hours after ventilation initiated to onset of pneumonia ]

      the incidence of VAP in patients intubated with the Taper guard tube is compared with the incidence of VAP in patients intubated with the ordinary tube. The criteria for diagnosing VAP is from the American Thoracic Society 2005 guidelines for VAP diagnosis. The assessor for VAP diagnosis is blinded
      
      
      

      Original Primary Outcome: Same as current
      
      

      Current Secondary Outcome:

      • Number of days on the ventilator by the time patient is discharged from ICU or hospital or at time of death [ Time Frame: participants will be followed for the duration of ventilation, an expected average of 2 weeks ]
        The number of days patient is on the ventilator will be monitored between the 2 groups
      • The total number of days spent in the intensive care unit by the time of discharge from hospital or death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
        The length of stay in the intensive care unit will be monitored between the 2 groups
      • The number of days spent in the hospital by the time of discharge or death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
        The length of stay in the hospital will be monitored for the 2 groups
      • number of deaths in each arm [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
        the rate of mortality between the 2 groups will be monitored
      
      
      

      Original Secondary Outcome: Same as current
      
      Information By: University of Malaya
      

      Dates:
      Date Received: December 12, 2011
      Date Started: February 2012
      Date Completion: December 2013
      Last Updated: December 28, 2011
      Last Verified: December 2011