Pneumonia in Tetanus Study

NCT01331252 | Completed

• 1 other identifier: BP
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tetanus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mortality between supine or semi-recumbent body position

  72 hours

Study Arms (2)

supine body position

EXPERIMENTAL

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

semi-recumbent

EXPERIMENTAL

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

Interventions

semi-recumbent OTHER

Patient rests in a semi-recumbent body position

semi-recumbent

supine OTHER

Patient rests in a supine position

supine body position

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator

Related Publications (1)

• 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.

  PMID: 22197012 DERIVED

MeSH Terms

Conditions

Tetanus

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christopher Parry, MD

  Oxford University CLinical Research Unit - Viet Nam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 8, 2011
• Study Start: August 1, 2000
• Primary Completion: March 1, 2002
• Study Completion: March 1, 2002
• Last Updated: September 15, 2011

Record last verified: 2011-09