Strategies To Prevent Pneumonia 2 (SToPP2)

Mechanical Ventilation Complication Clinical Trial

— SToPP2  

Official title:

Oral Care Intervention in Mechanically Ventilated Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893763
• Other study ID #: 2R01NR007652
• Secondary ID: R01NR007652
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2009
• Last updated: December 4, 2015
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: December 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated critically ill patients. The intervention tested in this project (swabbing the mouth with chlorhexidine before the endotracheal tube is inserted) could reduce the risk of ventilator-associated pneumonia.

Description:

Ventilator-associated pneumonia (VAP) is an acute care complication with high morbidity and mortality, which is costly in length of stay and resources used. Application of chlorhexidine (CHX) to the mouths of critically ill adults after intubation reduces risk of VAP. During intubation, organisms may be dragged by the tube from the contaminated mouth to the sterile lung, and the endotracheal tube (ET) provides a pathway for direct entry of bacteria from the mouth to the lower respiratory tract. However, procedures to decontaminate the mouth before intubation are not routine and little is known about the effects of pre-intubation CHX in critically ill patients. Thus, this project focuses on evaluating the benefit of adding a pre-intubation CHX dose to the known benefit of post-intubation CHX to reduce the risk of VAP. In order to examine the effect of pre-intubation CHX on early ET colonization, we will perform microbial cultures of ETs of subjects who are extubated in the first 24 hours of study participation. We will also explore selected biomarkers (procalcitonin, cytokines) as indicators of development of VAP in a subset of subjects. The project will add to knowledge about the relationships among oral health, ET intubation and VAP, and addresses an important clinical outcome. Pre-intubation oral decontamination could reduce risk of VAP and its associated morbidity and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Need for intubation

Exclusion Criteria:

• Pneumonia at the time of intubation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Hospital
• Mechanical Ventilation Complication
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia

Intervention

Procedure:
• Pre-intubation CHX
Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
• Control
No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Munro CL, Grap MJ, Sessler CN, Elswick RK Jr, Mangar D, Karlnoski-Everall R, Cairns P. Preintubation application of oral chlorhexidine does not provide additional benefit in prevention of early-onset ventilator-associated pneumonia. Chest. 2015 Feb;147(2) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of VAP (Clinical Pulmonary Infection Score)	Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.	Baseline up to 5 days	Yes
Secondary	Endotracheal Tube Colonization	semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization.	24 hours	Yes
Secondary	Serum Cytokines		5 days	Yes
Secondary	Serum Procalcitonin		5 days	Yes