Pneumonia in Tetanus Study

Tetanus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331252
• Other study ID #: BP
• Status: Completed
• Phase: N/A
• First received: April 5, 2011
• Last updated: September 14, 2011
• Start date: August 2000
• Est. completion date: March 2002

Study information

• Verified date: September 2011
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tetanus

Intervention

Other:
• semi-recumbent
Patient rests in a semi-recumbent body position
• supine
Patient rests in a supine position

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes