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Pneumonia in Tetanus Study (BP)

This study has been completed.
Sponsor:
Collaborator:
Hospital for Tropical Disease, HoChiMinh city, Vietnam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01331252
First received: April 5, 2011
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Tetanus
Other: semi-recumbent
Other: supine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia in patients nursed in a semi-recumbent or supine body position


Secondary Outcome Measures:
  • mortality between supine or semi-recumbent body position [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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


Enrollment: 200
Study Start Date: August 2000
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: supine body position
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
Other: supine
Patient rests in a supine position
Experimental: semi-recumbent
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
Other: semi-recumbent
Patient rests in a semi-recumbent body 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

  Eligibility

Ages Eligible for Study:   1 Year to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331252

Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Hospital for Tropical Disease, HoChiMinh city, Vietnam
Investigators
Principal Investigator: Christopher Parry, MD Oxford University CLinical Research Unit - Viet Nam
  More Information

No publications provided by Oxford University Clinical Research Unit, Vietnam

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01331252     History of Changes
Other Study ID Numbers: BP
Study First Received: April 5, 2011
Last Updated: September 14, 2011
Health Authority: Vietnam: Ho Chi Minh City Health Service

Additional relevant MeSH terms:
Tetanus
Tetany
Bacterial Infections
Calcium Metabolism Disorders
Clostridium Infections
Gram-Positive Bacterial Infections
Hypocalcemia
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014