Strategies To Prevent Pneumonia 2 (SToPP2) (SToPP2)

Oral Care Intervention in Mechanically Ventilated Adults

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication; Ventilator-Associated Pneumonia; Infections, Hospital
• Intervention / Treatment: Procedure: Pre-intubation CHX; Procedure: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298-0567
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Need for intubation

Exclusion Criteria:

• Pneumonia at the time of intubation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-intubation CHX; Chlorhexidine applied to oral cavity prior to intubation	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.
Active Comparator: Control; No chlorhexidine applied to oral cavity prior to intubation	Procedure: Control; No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Serum Cytokines		5 days
Serum Procalcitonin		5 days

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Cindy L Munro, RN,ANP,PHD, Virginia Commonwealth University

Publications and helpful links

General Publications

• 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):328-334. doi: 10.1378/chest.14-0692.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: May 4, 2009
• First Posted (Estimate): May 6, 2009

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Endotracheal intubation; Ventilator-Associated Pneumonia; Nosocomial (Hospital-Acquired) Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Cross Infection
• Other Study ID Numbers: 2R01NR007652 (U.S. NIH Grant/Contract); R01NR007652 (U.S. NIH Grant/Contract)