Pneumonia in Tetanus Study

Not Applicable

Completed

• Conditions: Tetanus
• Interventions: Other: supine; Other: semi-recumbent

• Registration Number: NCT01331252
• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

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 Timeline

• Study Start: 2000-08
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-14
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine body position	supine	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
semi-recumbent	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

Primary Outcome Measures

Name	Time	Method
assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia	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 Outcome Measures

Name	Time	Method
mortality between supine or semi-recumbent body position	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