Pneumonia in Tetanus Study

Brief Title

Pneumonia in Tetanus Study

Official Title

Can the Incidence of Nosocomial Pneumonia in Severe Tetanus be Reduced by Nursing Patients Semi-recumbent? A Randomised Comparison of Supine or Semi-recumbent Body Position

Brief Summary

      This is a randomised controlled trial of the incidence of nosocomial pneumonia in patients
      with severe tetanus admitted to the intensive care ward nursed in a supine or semi-recumbent
      position.
    

Detailed Description

      Background: Hospital-acquired pneumonia remains a common and important cause of morbidity and
      mortality in patients with severe tetanus who require a tracheostomy whether or not they are
      mechanically ventilated. We propose to investigate if the incidence of hospital-acquired
      pneumonia can be reduced by nursing tetanus patients semi-recumbent at 30o rather than supine
      as is the current practice.

      The aim of this study will be to assess the frequency of clinically suspected and
      microbiologically confirmed hospital acquired pneumonia in patients nursed in a
      semi-recumbent or supine body position. A secondary end-point will be the mortality in each
      group. Patients at risk of developing hospital acquired pneumonia (in hospital without
      developing pneumonia for more than two days) will be evaluated
    


Study Type

Interventional


Primary Outcome

assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia

Secondary Outcome

 mortality between supine or semi-recumbent body position

Condition

Tetanus

Intervention

semi-recumbent

Study Arms / Comparison Groups

 supine body position
Description:  Consecutive patients admitted with severe tetanus to the tetanus intensive care ward will be eligible to be included in the study. An envelope for the next study number will be opened in which patients will be randomly allocated to either semi-recumbent (30 degree) or supine (0 degree) body position

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

200

Start Date

August 2000

Completion Date

March 2002

Primary Completion Date

March 2002

Eligibility Criteria

        Inclusion Criteria:

          1. Consecutive patients will be entered into the study as they are admitted to the
             intensive care ward with a clinical diagnosis of tetanus.

          2. Informed consent will be obtained from the patient or next-of-kin before
             randomisation.

          3. An envelope for the next study number will be opened in which patients will be
             randomly allocated to either semi-recumbent (300) or supine (00) body position. The
             randomisation will be created by a computer generated list.

          4. All health care personnel will be instructed not to change the position, unless for
             medical requirements.

          5. The correctness of the position will be checked twice daily.

          6. Surveillance for clinical detection of pneumonia or other infection will be done
             daily. If infection is suspected relevant microbiological samples will be taken.

          7. The study period will end 72 hours after the patient has left the intensive care ward,
             or if there is a permanent change in body position for more than 1 hour or death.

        Exclusion Criteria:

          1. Recent abdominal surgery (<7 days)

          2. Shock refractory to vasoactive drugs or volume therapy

          3. Recent intensive care (<30 days)

          4. Neonates

          5. Pneumonia at the time of admission to intensive care.
      

Gender

All

Ages

1 Year - 90 Years

Accepts Healthy Volunteers

No

Contacts

Christopher Parry, MD, , 



Administrative Informations


NCT ID

NCT01331252

Organization ID

BP


Responsible Party

Sponsor

Study Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

 Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Study Sponsor

Christopher Parry, MD, Principal Investigator, Oxford University CLinical Research Unit - Viet Nam


Verification Date

September 2011