Back to resultsPneumonia in Tetanus Study (BP)
Primary Purpose
Tetanus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
semi-recumbent
supine
Sponsored by
About this trial
This is an interventional supportive care trial for Tetanus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
supine body position
semi-recumbent
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01331252
First Posted
April 5, 2011
Last Updated
September 14, 2011
Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
1. Study Identification
Unique Protocol Identification Number
NCT01331252
Brief Title
Pneumonia in Tetanus Study
Acronym
BP
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supine body position
Arm Type
Experimental
Arm Description
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
Arm Title
semi-recumbent
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
semi-recumbent
Intervention Description
Patient rests in a semi-recumbent body position
Intervention Type
Other
Intervention Name(s)
supine
Intervention Description
Patient rests in a supine position
Primary Outcome Measure Information:
Title
assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia
Description
assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia in patients nursed in a semi-recumbent or supine body position
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
mortality between supine or semi-recumbent body position
Description
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
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Parry, MD
Organizational Affiliation
Oxford University CLinical Research Unit - Viet Nam
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22197012
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.
Results Reference
derived
Learn more about this trial
Pneumonia in Tetanus Study
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