Trial Outcomes & Findings for Strategies To Prevent Pneumonia 2 (SToPP2) (NCT NCT00893763)

Last Updated: 2016-01-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

314 participants

Primary outcome timeframe

Baseline up to 5 days

Results posted on

2016-01-11

Participant Flow

Subjects were enrolled from two large urban teaching medical centers (VCU Health System, Tampa General Hospital). Subjects were recruited in multiple clinical areas just prior to intubation, including critical care units, emergency departments, pre-operative areas, procedural areas, and medical-surgical units during rapid response or code calls.

Participant milestones

Participant milestones
Measure	1: Preintubation Oral Chlorhexidine Intervention: 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.	2: Control Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Overall Study STARTED	157	157
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	110	110

Reasons for withdrawal

Reasons for withdrawal
Measure	1: Preintubation Oral Chlorhexidine Intervention: 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.	2: Control Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Overall Study extubated	110	110

Baseline Characteristics

Strategies To Prevent Pneumonia 2 (SToPP2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: Preintubation Oral Chlorhexidine n=157 Participants Intervention: 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.	2: Control n=157 Participants Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation	Total n=314 Participants Total of all reporting groups
Age, Continuous	58.08 years STANDARD_DEVIATION 15.85 • n=5 Participants	58.20 years STANDARD_DEVIATION 16.19 • n=7 Participants	58.12 years STANDARD_DEVIATION 16.01 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	98 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	59 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	152 Participants n=5 Participants	153 Participants n=7 Participants	305 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants	56 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) White	106 Participants n=5 Participants	96 Participants n=7 Participants	202 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	157 participants n=7 Participants	314 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 days

Population: Subjects who had complete CPIS data on admission to the study (Day 0) and subsequent complete CPIS data from day 2, 3, 4 or 5 (47 CHX \& 47 control, 438 observations) were included in the analysis in accordance with intent to treat analysis principles.

Outcome measures

Outcome measures
Measure	1: Preintubation Intervention n=47 Participants Intervention: 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.	2: COntrol n=47 Participants Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Development of VAP (Clinical Pulmonary Infection Score)	4.13 units on a scale Standard Error 0.28	4.45 units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: 24 hours

Population: The subjects analyzed were a subset of subjects enrolled in the study from whom endotracheal tunes were obtainable for microbial culture post-intubation. Subset analysis was planned a priori.

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.

Outcome measures

Outcome measures
Measure	1: Preintubation Intervention n=43 Participants Intervention: 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.	2: COntrol n=40 Participants Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Endotracheal Tube Colonization	18.6 percentage of ET tubes colonized	17.5 percentage of ET tubes colonized

SECONDARY outcome

Timeframe: 5 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 days

Outcome measures

Outcome data not reported

Adverse Events

1: Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2: Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cindy L. Munro, APRN, PhD

University of South Florida

Phone: 813-974-7597

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place