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Completed

NCT Number: NCT01331252

Pneumonia in Tetanus Study

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.

Completed

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Key information

Age range

1 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients will be entered into the study as they are admitted to the intensive care ward with a clinical diagnosis of tetanus.
  • Informed consent will be obtained from the patient or next-of-kin before randomisation.
  • 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.
  • All health care personnel will be instructed not to change the position, unless for medical requirements.
  • The correctness of the position will be checked twice daily.
  • Surveillance for clinical detection of pneumonia or other infection will be done daily. If infection is suspected relevant microbiological samples will be taken.
  • 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

  • Recent abdominal surgery (<7 days)
  • Shock refractory to vasoactive drugs or volume therapy
  • Recent intensive care (<30 days)
  • Neonates
  • Pneumonia at the time of admission to intensive care.

Treatment and study plan

semi-recumbent

Other

Patient rests in a semi-recumbent body position

supine

Other

Patient rests in a supine position

Primary outcomes

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

    Time frame: 72 hours

    assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia in patients nursed in a semi-recumbent or supine body position

Secondary outcomes

  1. mortality between supine or semi-recumbent body position

    Time frame: 72 hours

    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

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Registry information

Official study 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

Acronym: BP

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Apr 8, 2011
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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