Clinical trial NCT01331252: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetanus
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
First posted: 2011-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia
timeFrame: 72 hours
Secondary outcomes:
measure: mortality between supine or semi-recumbent body position
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
affiliation: Oxford University CLinical Research Unit - Viet Nam
name: Christopher Parry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loan HT, Parry J, Nga NT, Yen LM, Binh NT, Thuy TT, Duong NM, Campbell JI, Thwaites L, Farrar JJ, Parry CM. Semi-recumbent body position fails to prevent healthcare-associated pneumonia in Vietnamese patients with severe tetanus. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):90-7. doi: 10.1016/j.trstmh.2011.10.010. Epub 2011 Dec 22.