Pneumonia in Tetanus Study (BP)

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

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.

Study Overview

• Status: Completed
• Conditions: Tetanus
• Intervention / Treatment: Other: supine; Other: semi-recumbent

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
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia	assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia in patients nursed in a semi-recumbent or supine body position	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality between supine or semi-recumbent body position	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	72 hours

Collaborators and Investigators

• Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborators: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
• Investigators: Principal Investigator: Christopher Parry, MD, Oxford University Clinical Research Unit - Viet Nam

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): March 1, 2002
• Study Completion (Actual): March 1, 2002

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): September 15, 2011
• Last Update Submitted That Met QC Criteria: September 14, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Neurologic Manifestations; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Pneumonia; Tetanus; Tetany
• Other Study ID Numbers: BP